Mask system

ABSTRACT

A mask system for delivery of respiratory therapy to a patient includes a nares portion and a mouth portion and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas. The mask system is adapted to selectively utilize the nares portion and/or the mouth portion in a first mode utilizing both the nares portion and the mouth portion, and in a second mode utilizing the nares portion and not utilizing the mouth portion.

CROSS-REFERENCE TO APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/652,671, filed Jul. 18, 2017, which is a continuation of U.S.application Ser. No. 13/876,606, filed Mar. 28, 2013, now U.S. Pat. No.9,737,678, which is the U.S. national phase of International ApplicationNo. PCT/AU2011/001259, filed Sep. 30, 2011, which designated the U.S.and claims the benefit of U.S. Provisional Application Nos. 61/388,357,filed Sep. 30, 2010, 61/443,623, filed Feb. 16, 2011, 61/457,981, filedJul. 27, 2011, and 61/528,524, filed Aug. 29, 2011, each of which isincorporated herein by reference in its entirety.

FIELD OF THE TECHNOLOGY

The present technology relates to a mask system used for Non-invasivePositive Pressure Ventilation (NPPV) and for continuous positive airwaypressure (CPAP) therapy of sleep disordered breathing (SDB) conditionssuch as obstructive sleep apnea (OSA).

BACKGROUND OF THE TECHNOLOGY

Treatment of sleep disordered breathing (SDB), such as obstructive sleepapnea (OSA), by continuous positive airway pressure (CPAP) flowgenerator systems involves the continuous delivery of air (or otherbreathable gas) pressurized above atmospheric pressure to the airways ofa human or other mammalian patient via a conduit and a mask. Typically,the mask fits over or in the mouth and/or nose of the patient.Pressurized air flows to the mask and to the airways of the patient viathe nose and/or mouth. Pressurized air is delivered to the mask by aconduit connected to the CPAP device and the mask.

The mask should be comfortable and unobtrusive so that a patient maytolerate their therapy and maintain usage. Some patients may prefer apillows or prongs type mask (as known in the art), or a nasal mask or afull face mask. Some patient's may prefer to use one or a combination ofthese masks interchangeably. However, this would require the purchase ofa number of different mask systems, which may be expensive and/or maynot be covered by insurance.

In addition, masks including oro-nasal masks typically include a rigidframe. Patients may not find this comfortable. The frame may alsodislodge the sealing portion of the mask away from the face of thepatient if it is contacted or forced by bed clothing, pillows, etc.

SUMMARY OF THE TECHNOLOGY

One aspect of the present technology relates to a mask system that isable to be used as either a nasal only type mask or an oro-nasal mask.

Another aspect of the present technology relates to an oro-nasal maskthat is substantially comprised of flexible components.

Another aspect of the present technology relates to an oro-nasal maskthat is stabilised at the nose sealing portion separately to the mouthsealing portion.

Another aspect of the present technology relates to an oro-nasal maskhaving at least a first headgear connection on the nasal portion of themask and at least a second headgear connection on the mouth portion ofthe mask.

Another aspect of the present technology relates to a modular masksystem that is adapted to be used in a nares only configuration, or in anares and mouth configuration.

Another aspect of the present technology relates to a modular masksystem that is adapted to be used in a nares only configuration, in amouth only configuration, or in a nares and mouth configuration.

In one form of the present technology, the mask system is provided witha nares portion and a mouth portion that are useable at the option ofthe patient with the nares portion and the mouth portion, or with justthe nares portion. The mouth portion when used with the nares portionmay be used to deliver respiratory therapy to the patient's mouth, ormay be used as a mouth seal.

In one form of the present technology, the mask system is provided witha nares portion and a mouth portion that are useable at the option ofthe patient with the nares portion and the mouth portion, with just thenares portion, or with just the mouth portion.

In one form of the present technology, the mask system is provided witha nares portion and a mouth portion, where the nares portion includes anares sealing portion adapted to form a seal with the patient's nares,where the nares sealing portion is structured to extend or curveoutwardly from a supporting wall defining an air path into the naressealing portion.

Another aspect of the present technology relates to a mask system thatincludes a nares portion and a mouth portion, and the mouth portion isadapted to be used in both a first configuration where at least aportion of the pressurized, breathable gas is delivered to the patient'smouth and in a second configuration where the mouth portion functions asa mouth seal that prevents any of the pressurized, breathable gas frombeing delivered to the patient's mouth.

Another aspect of the present technology relates to a method ofproviding a mask system kit for delivering respiratory therapy to apatient, where a nares portion and a mouth portion are useable at theoption of the patient with the nares portion and the mouth portion, withjust the nares portion, or with just the mouth portion.

Another aspect of the present technology relates to a method ofproviding a mask system kit for delivering respiratory therapy to apatient, where a nares portion and a mouth portion are useable at theoption of the patient with the nares portion and the mouth portion, withjust the nares portion, or with just the mouth portion, where the whenthe nares portion and the mouth portion are both utilized, the naresportion and the mouth portion may both be utilized to deliverpressurized air to the nares and mouth of the patient, respectively, orone of the nares portion and the mouth portion may be utilized todeliver pressurized air to the nares or mouth of the patient, while theother of the nares portion and the mouth portion is utilized as a naresor mouth seal.

Another aspect of the present technology relates to a method ofconverting a mask system having a nares portion and a mouth portionbetween first and second modes, where in the first mode the mask systemis useable with the nares portion and the mouth portion, and in thesecond mode the mask system is useable with only the nares portion.

Another aspect of the present technology relates to a kit providing anares only portion for delivering respiratory therapy to a patient'snares, the nares portion adapted to function with a mouth portion.

Another aspect of the present technology relates to a kit providing amouth portion for delivering respiratory therapy to a patient's mouth,the mouth portion adapted to function with a nares portion.

Another aspect of the present technology relates to a method ofproviding respiratory therapy to one of a patient's nares only, apatient's mouth only, or to both a patient's nares and mouth, andperiodically changing the respiratory therapy to another of thepatient's nares only, the patient's mouth only, or to both the patient'snares and mouth.

Another aspect of the present technology relates to a method ofrespiratory therapy treatment, where a first mask with a first footprintis applied to a patient for a period of time, then the first mask isremoved, and a second mask with a second footprint different from thefirst footprint is applied to the patient for a second period of time.

Another aspect of the present technology relates to a mouth portion fordelivering respiratory therapy to a patient's mouth, the mouth portionincluding a docking station adapted to receive a nares portion, whereinthe nares portion is capable of functioning as a nares only device fordelivering pressurized gas to the nares of a patient.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion adapted to form a seal with the patient's nares, a mouthportion including a mouth chamber and a mouth sealing portion adapted toform a seal with the patient's mouth, the mouth chamber including anopening adapted to selectively receive pressurized, breathable gas, aninlet conduit connected to at least one of the nares portion and themouth portion to deliver the pressurized, breathable gas, wherein themask system is adapted to selectively utilize the nares portion and/orthe mouth portion in a first mode utilizing both the nares portion andthe mouth portion, and in a second mode utilizing the nares portion andnot utilizing the mouth portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion adapted to form a seal with the patient's nares, a mouthportion including a mouth chamber and a mouth sealing portion adapted toform a seal with the patient's mouth, an inlet conduit connected to atleast one of the nares portion and the mouth portion to deliverpressurized, breathable gas to the patient, wherein the nares portionand the mouth portion are adapted to connect to each other, and themouth portion is adapted to selectively function in both a firstconfiguration where at least a portion of the pressurized, breathablegas is delivered to the patient's mouth and in a second configurationwhere the mouth portion functions as a mouth seal that prevents any ofthe pressurized, breathable gas from being delivered to the patient'smouth.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga sealing portion including a nares sealing portion and a mouth sealingportion, the nares sealing portion adapted to form a seal with thepatient's nares, the nares sealing portion structured to extend or curveoutwardly from a supporting wall defining an air path into the naressealing portion, the mouth sealing portion adapted to form a seal withthe patient's mouth, the sealing portion adapted to connect to at leastone inlet conduit to receive a supply of pressurized, breathable gas andheadgear for retaining the sealing assembly in position on the head ofthe patient.

Another aspect of the present technology relates to a method ofproviding a mask system kit for delivering respiratory therapy to apatient, the method including providing a nares portion adapted to forma seal with the patient's nares, providing a mouth portion including amouth chamber and a mouth sealing portion adapted to form a seal withthe patient's mouth, the mouth chamber including an opening adapted toselectively receive pressurized, breathable gas, and providing an inletconduit connectable to at least one of the nares portion and the mouthchamber to deliver the pressurized, breathable gas, wherein, at theoption of the patient, the mask system is adapted to selectively utilizethe nares portion and/or the mouth portion in at least first and secondmodes, the first mode utilizing the nares portion and the mouth portionto provide the respiratory therapy to the patient's nares, wherein themouth portion is configured to provide the respiratory therapy to thepatient's mouth or to seal the mouth portion, and in the second modeutilizing the nares portion to provide the respiratory therapy to thepatient's nares and not utilizing the mouth portion as a seal or todeliver respiratory therapy.

Another aspect of the present technology relates to a method ofconverting a mask system between first and second modes, the mask systemfor delivery of respiratory therapy to a patient, the method includingproviding a nares portion adapted to form a seal with the patient'snares, providing a mouth portion including a mouth chamber and a mouthsealing portion adapted to form a seal with the patient's mouth, themouth chamber including an opening adapted to selectively receivepressurized, breathable gas, assembling the mask system in the firstmode utilizing the nares portion and the mouth portion to provide therespiratory therapy to the patient's nares, utilizing the mouth portionto provide the respiratory therapy to the patient's mouth or utilizingthe mouth portion as a mouth seal, and converting the mask system in thesecond mode utilizing the nares portion to provide the respiratorytherapy to the patient's nares and not utilizing the mouth portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga mouth portion including a mouth chamber and a mouth sealing portionadapted to form a seal with the patient's mouth, the mouth chamberincluding an opening adapted to selectively receive pressurized,breathable gas, and a nares portion docking station formed on the mouthportion, the nares portion docking station adapted to receive a naresportion, wherein the nares portion is capable of functioning as a naresonly device for delivering pressurized gas to the nares of the patient.

Another aspect of the present technology relates to a medical packageincluding a kit for converting a CPAP device comprising a nares onlyportion to a CPAP device having a nares and a mouth portion, the medicalpackage including a mouth portion including a mouth chamber and a mouthsealing portion adapted to form a seal with the patient's mouth, themouth chamber including an opening adapted to selectively receivepressurized, breathable gas, a vent plug adapted to plug an aperture inthe nares only portion, and headgear adapted to secure at least themouth portion to a patient's head.

Another aspect of the present technology relates to a system kit adaptedto convert a nares only device for delivering respiratory therapy to apatient into a nares and mouth device for delivering respiratory therapyto a patient, the system kit including a mouth portion including a mouthchamber and a mouth sealing portion adapted to form a seal with thepatient's mouth, the mouth chamber including an opening adapted toselectively receive pressurized, breathable gas, the mouth portionadapted to function with the nares only device as a nares and mouthdevice, a plug adapted to connect to either the opening in the mouthchamber or an opening in the nares only device, and headgear adapted tosecure at least the mouth portion to the patient's head.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion adapted to form a seal with the patient's nares, a mouthportion including a mouth chamber and a mouth sealing portion adapted toform a seal with the patient's mouth, and a double elbow, e.g., havingone branch connected to the nares portion and another branch connectedto the mouth portion to deliver the pressurized breathable gas to thenares portion and the mouth portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion adapted to form a seal with the patient's nares, a mouthportion including a mouth chamber and a mouth sealing portion adapted toform a seal with the patient's mouth, and a covering flap extending fromthe mouth portion to cover the nares portion and/or the patient's naresin use.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion adapted to form a sealwith the patient's nares, a mouth portion including a mouth sealingportion adapted to form a seal with the patient's mouth, the mouthsealing portion being oriented generally horizontally and the naressealing portion being oriented generally vertically.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, the nares supportingportion being a semi-rigid material and the nares sealing portion beinga flexible material.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, the mouth portionand/or the nares portion including a magnet to retain the mouth portionand/or the nares portion in position.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion adapted to form a seal with the patient's nares, a mouthportion adapted to form a seal with the patient's mouth, and a foamportion adapted to clip onto at least one of the nares portion and themouth portion to form a seal between the mask system and the patient.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, and a connecting ringadapted to connect the mouth portion to the nares portion, theconnecting ring having a first channel adapted to receive the mouthportion and a second channel adapted to receive the nares portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, wherein the naressealing portion has indentations adapted to form an interference fitwith the mouth portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, upper headgear adaptedto connect to the nares portion, the upper headgear including a backstrap adapted to wrap around a back of the patient's head, and lowerheadgear adapted to connect to the mouth portion, the lower headgearhaving a loop adapted to receive the back strap of the upper headgear.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion adapted to form a sealwith the patient's nares, an elbow connected to the nares portion todeliver pressurized gas, the elbow including a lug portion, a mouthportion including a mouth sealing portion adapted to form a seal withthe patient's mouth, the mouth portion including an aperture selectivelyconnectable to the lug portion of the elbow to connect the mouth portionto the nares portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion adapted to form a sealwith the patient's nares, a mouth portion including a mouth sealingportion adapted to form a seal with the patient's mouth, the mouthsealing portion including a cushion having a pocket or lower stiffnessregion, shaped and adapted to receive the nares portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga nares portion including a nares sealing portion and a nares supportingportion, the nares sealing portion adapted to form a seal with thepatient's nares, a mouth portion including a mouth sealing portionadapted to form a seal with the patient's mouth, the mouth portionincluding a cushion and a cushion fascia portion, the cushion fasciaportion adapted to connect to the cushion, the cushion having aconnecting portion with an aperture, the aperture adapted to receive aring to connect the nares portion to the mouth portion.

Another aspect of the present technology relates to a mask system fordelivery of respiratory therapy to a patient, the mask system includinga mouth portion including a mouth sealing portion adapted to form a sealwith the patient's mouth, the mouth sealing portion not comprising apocket.

Other aspects, features, and advantages of the present technology willbecome apparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousexamples of this technology. In such drawings:

FIG. 1-1 depicts a front view of a mask system in a nares only mode on amodel patient's head according to an embodiment of the presenttechnology;

FIG. 1-2 depicts a front view of a mask system on a model patient's headin a nares and mouth mode according to an embodiment of the presenttechnology;

FIG. 1-3 depicts a front view of a mask system on a model patient's headin a nares and mouth mode according to an embodiment of the presenttechnology;

FIG. 1-4 depicts a front view of a mask system on a model patient's headin a mouth only mode according to an embodiment of the presenttechnology;

FIG. 1-5 depicts a front exploded view of a mask system illustrating howthe nares portion may connect to the mouth portion according to anembodiment of the present technology;

FIG. 2 depicts a front view of the mask system of FIGS. 1-1 to 1-5without the elbow connector according to an embodiment of the presenttechnology;

FIG. 3 depicts a rear view of the mask system of FIGS. 1-1 to 1-5according to an embodiment of the present technology;

FIG. 4 depicts a rear isometric view of the mask system of FIGS. 1-1 to1-5 according to an embodiment of the present technology;

FIG. 5-1 depicts a front isometric view of a mask system on a modelpatient's head according to another embodiment of the presenttechnology;

FIG. 5-2 depicts a front isometric view of the mask system of FIG. 5-1on a model patient's head in a nares only mode;

FIG. 6 depicts a side view of the mask system of FIG. 5 in use accordingto an embodiment of the present technology;

FIG. 7 depicts a rear isometric view of a headgear utilized with themask system of FIG. 5-1 according to an embodiment of the presenttechnology;

FIG. 8 depicts a front isometric view of the mask system of FIG. 5-1without the elbow connector according to an embodiment of the presenttechnology;

FIG. 9 depicts a front view of the mask system of FIG. 5-1 without theelbow connector according to an embodiment of the present technology;

FIG. 10 depicts a top view of the mask system of FIG. 5-1 without thenares portion according to an embodiment of the present technology;

FIG. 11 depicts a rear isometric view of the mask system of FIG. 5-1according to an embodiment of the present technology;

FIG. 12 depicts a rear view of the mask system of FIG. 5-1 according toan embodiment of the present technology;

FIG. 13 depicts a front view of a portion of the mask system of FIG. 5-1without the nares portion and without the elbow connector and includinga headgear according to an embodiment of the present technology;

FIG. 14 depicts a front view of a mask system on a model patient's headaccording to another embodiment of the present technology;

FIG. 15 depicts a side view of the mask system of FIG. 14 on a modelpatient's head according to an embodiment of the present technology;

FIG. 16 depicts a rear view of a mask system with a decoupling portionand connecting portion removed according to another embodiment of thepresent technology;

FIG. 17 depicts a front isometric view of the mask system of FIG. 16according to an embodiment of the present technology;

FIG. 18 depicts a front isometric view of the mask system of FIG. 16according to an embodiment of the present technology;

FIG. 19 depicts a rear isometric view of a nares portion that may beused with mask systems according to an embodiment of the presenttechnology;

FIG. 20 depicts a front isometric view of the nares portion of FIG. 19according to an embodiment of the present technology;

FIG. 21 depicts a front isometric view of a mask system on a modelpatient's head in a nares only mode according to another embodiment ofthe present technology;

FIG. 22 depicts a front isometric view the mask system of FIG. 21 on amodel patient's head in a nares and mouth configuration according to anembodiment of the present technology;

FIG. 23 depicts a front isometric view of a mask system on a modelpatient's head according to another embodiment of the presenttechnology;

FIG. 24 depicts a side view of a mask system on a model patient's headaccording to another embodiment of the present technology;

FIG. 25 depicts a side view of a mask system on a model patient's headaccording to another embodiment of the present technology;

FIG. 26 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 27 depicts a schematic cross-sectional view of an integrated masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 28 depicts a schematic cross-sectional view of an integrated masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 29-1 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 29-2 depicts a schematic top view of a mouth sealing portion of themask system of FIG. 29-1 according to an embodiment of the presenttechnology;

FIG. 29-3 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 30-1 depicts a schematic cross-sectional view of a modular mask ona model patient's head according to an embodiment of the presenttechnology;

FIG. 30-2 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 31 depicts a cross-sectional view of an integrated mask system on amodel patient's head according to an embodiment of the presenttechnology;

FIGS. 32(a)-(k) are schematic views the flow of pressurized gas throughthe mask system various configurations according to embodiments of thepresent technology;

FIG. 33 depicts a schematic view of a nares and mouth kit according toembodiments of the present technology;

FIG. 34 depicts a schematic view of a modular mask system on a modelpatient's head according to an embodiment of the present technology;

FIG. 35 depicts a front view of a nares sealing portion according to anembodiment of the present technology;

FIG. 36 depicts a front perspective view of the nares sealing portion ofFIG. 35 according to an embodiment of the present technology;

FIG. 37 depicts a prior art nares only CPAP device on a model patient'shead;

FIG. 38 depicts a retrofit kit used to convert the nares only CPAPdevice of FIG. 37 into a nares and mouth CPAP device according to anembodiment of the present technology;

FIG. 39 depicts a retrofit kit used to convert the nares only CPAPdevice of FIG. 37 into a nares and mouth CPAP device according to anembodiment of the present technology;

FIG. 40 depicts a prior art nares only CPAP device;

FIG. 41 depicts a retrofit kit to convert the nares only CPAP device ofFIG. 40 into a nares and mouth CPAP device illustrated on a modelpatient's head according to an embodiment of the present technology;

FIG. 42 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 43 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 44 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 44A is a cross-sectional view of a nares portion according to anembodiment of the present technology;

FIG. 44B is a cross-sectional view of a nares portion according to anembodiment of the present technology;

FIG. 45 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 46 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 47 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 48 depicts a schematic partial cross-sectional view of a modularmask system according to an embodiment of the present technology;

FIG. 49 is an exploded view of a modular mask system on a modelpatient's head according to an embodiment of the present technology;

FIG. 50 depicts a schematic cross-sectional view of an integrated (ormodular) mask system on a model patient's head according to anembodiment of the present technology;

FIG. 51 depicts a perspective view of the integrated (or modular) masksystem of FIG. 50 on a model patient's head;

FIG. 52 depicts a side view of the integrated (or modular) mask systemof FIG. 51 ;

FIG. 53 depicts schematic cross-sectional view of a modular mask systemon a model patient's head according to an embodiment of the presenttechnology;

FIG. 54 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 55 depicts a rear view of a nasal portion of a mask systemaccording to an embodiment of the present technology;

FIG. 55A is a cross-sectional view through line 55A-55A of FIG. 55 ;

FIG. 56 depicts a rear view of a nasal portion of a mask systemaccording to an embodiment of the present technology;

FIG. 56A is a cross-sectional view through line 56A-56A of FIG. 56 ;

FIG. 57 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 58 depicts a side view of an integrated or modular mask system on amodel patient's head according to an embodiment of the presenttechnology;

FIG. 59 depicts a perspective view of an integrated or modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 60 depicts a rear view of a modular mask system according to anembodiment of the present technology;

FIG. 61 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 62 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 63 depicts an exploded view of a modular mask system according toan embodiment of the present technology;

FIG. 64 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 65 depicts a schematic cross-sectional view of a modular masksystem on a model patient's head according to an embodiment of thepresent technology;

FIG. 66 depicts an exploded view of a modular mask system according toan embodiment of the present technology;

FIG. 67 depicts an exploded view of a modular mask system according toan embodiment of the present technology;

FIG. 68 depicts a perspective view of a modular mask system according toan embodiment of the present technology;

FIG. 69 depicts a front view of the modular mask system of FIG. 68 ;

FIG. 70 depicts a top view of the modular mask system of FIG. 68 ;

FIG. 71 depicts a bottom view of the modular mask system of FIG. 68 ;

FIG. 72 depicts a side view of the modular mask system of FIG. 68 ;

FIG. 73 depicts a cross sectional view along lines 73-73 from FIG. 69 ;

FIG. 74 depicts a perspective view of a nares portion of the mask systemof FIG. 68 ;

FIG. 75 depicts a perspective view of a mouth portion of the mask systemof FIG. 68 ;

FIG. 76 depicts a perspective view of the cushion portion of the masksystem of FIG. 68 ;

FIG. 77 depicts a front view of the cushion portion of the mask systemof FIG. 68 ;

FIG. 78 depicts a top view of the cushion portion of the mask system ofFIG. 68 ;

FIG. 79 depicts a bottom view of the cushion portion of the mask systemof FIG. 68 ;

FIG. 80 depicts a cross sectional view along lines 80-80 from FIG. 77 ;

FIG. 81 depicts a cross sectional view along lines 81-81 from FIG. 77 ;

FIG. 82 depicts a cross sectional view along lines 82-82 from FIG. 77 ;

FIG. 83 depicts a cross sectional view along lines 83-83 from FIG. 77 ;

FIG. 84 depicts a cross sectional view along lines 84-84 from FIG. 77 ;

FIG. 85 depicts a cross sectional view along lines 85-85 from FIG. 77 ;

FIG. 86 depicts a rear view of the cushion portion of the mask system ofFIG. 68 ;

FIG. 87 depicts a right side view of the cushion portion of the masksystem of FIG. 68 ;

FIG. 88 depicts a left side view of the cushion portion of the masksystem of FIG. 68 ;

FIG. 89 depicts a perspective view of the cushion portion of the masksystem of FIG. 68 ;

FIGS. 90, 91A, and 91B illustrate a headgear system that is convertiblebetween two point and four point support in accordance with a sample ofthe current technology;

FIGS. 92A to 92E and 93A to 931 illustrate a mouth cushion according toa variant of the current technology;

FIGS. 94-102 illustrate a cushion-to-fascia connection according to anexample of the present technology;

FIG. 103 illustrates a lip seal according to an example of the presenttechnology;

FIG. 104 is an exploded assembly view of a mask system according to anembodiment of the present technology;

FIG. 105 is a rear view of the mask system of FIG. 104 in the assembledstate;

FIG. 106 is a top view of the mask system of FIG. 104 in the assembledstate;

FIG. 107 is a bottom view of the mask system of FIG. 104 in theassembled state;

FIG. 108 is a left side view of the mask system of FIG. 104 in theassembled state;

FIG. 109 is a cross section view along the line 109-109 in FIG. 105 ;

FIG. 110 is a cross section view along the line 110-110 in FIG. 105 ;

FIG. 111 is a detailed view of a portion of FIG. 110 ;

FIG. 112 is a rear isometric view of the mouth cushion of the masksystem of FIG. 104 ;

FIG. 113 is a front isometric view of the mouth cushion of the masksystem of FIG. 104 ;

FIG. 114 is front view of the mouth cushion of the mask system of FIG.104 ;

FIG. 115 is a top view of the mouth cushion of the mask system of FIG.104 ;

FIG. 116 is a bottom view of the mouth cushion of the mask system ofFIG. 104 ;

FIG. 117 is a right side view of the mouth cushion of the mask system ofFIG. 104 ;

FIG. 118 is a front view of the mouth cushion of the mask system of FIG.104 ;

FIG. 119 is a cross section view of the mouth cushion along the line119-119 in FIG. 118 ;

FIG. 120 is a cross section view of the mouth cushion along the line120-120 in FIG. 118 ;

FIG. 121 is a cross section view of the mouth cushion along the line121-121 in FIG. 118 ;

FIG. 122 is a cross section view of the mouth cushion along the line122-122 in FIG. 118 ;

FIG. 123 is a cross section view of the mouth cushion along the line123-123 in FIG. 118 ;

FIG. 124 is a cross section view of the mouth cushion along the line124-124 in FIG. 118 ;

FIG. 125 is a rear isometric view of the cushion clip of the mask systemof FIG. 104 ;

FIG. 126 is a front isometric view of the cushion clip of FIG. 125 ;

FIG. 127 is a top view of the cushion clip of FIG. 125 ;

FIG. 128 is a bottom view of the cushion clip of FIG. 125 ;

FIG. 129 is a left side view of the cushion clip of FIG. 125 ;

FIG. 130 is a rear view of the cushion clip of FIG. 125 ;

FIG. 131 is a cross section view along lines 131-131 in FIG. 130 ;

FIG. 132 is a front isometric view of a fascia of the mask system ofFIG. 104 ;

FIG. 133 is a front view of the fascia of FIG. 132 ;

FIG. 134 is a rear view of the fascia of FIG. 132 ;

FIG. 135 is a top view of the fascia of FIG. 132 ;

FIG. 136 is a bottom view of the fascia of FIG. 132 ;

FIG. 137 is a right side view of the fascia of FIG. 132 ;

FIG. 138 is a cross section view along the line 138-138 in FIG. 133 ;

FIG. 139 is a front isometric view of a cushion clip according to anembodiment of the present technology;

FIG. 140 is a rear isometric view of the cushion clip of FIG. 139 ;

FIG. 141 is a front view of the cushion clip of FIG. 139 ;

FIG. 142 is a top view of the cushion clip of FIG. 139 ;

FIG. 143 is a bottom view of the cushion clip of FIG. 139 ;

FIG. 144 is a left side view of the cushion clip of FIG. 139 ; and

FIG. 145 is a cross section view along lines 145-145 in FIG. 141 .

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. It is acknowledged that the CPAP flowgenerator systems or blowers described herein may be designed to pumpfluids other than air.

1. Mask System

The mask system of the present technology delivers pressurizedbreathable gas to the patient and includes a nares portion, a mouthportion, a positioning and stabilizing structure, and an air deliverysystem. A sealing portion may be included with the nares portion and/orthe mouth portion to form a seal or substantially seal with the noseand/or mouth of the patient. One or more vents may also be included tovent gas exhaled by the patient on the nares portion and/or the mouthportion. However, the mask may be non-vented and be used in ahospital/ventilation scenario. The mask system my also be provided withan anti-asphyxia valve (AAV).

The sealing portion is arranged to form a seal or substantially sealwith the nose and/or mouth of the patient to deliver pressurized gas tothe patient. Preferably, the sealing portion has a nares sealing portionand a mouth sealing portion. The nares sealing portion and the mouthsealing portion may be integrally formed, or they may be in the form ofseparate elements. The nares sealing portion and mouth sealing portionmay be connected or otherwise positioned so as to independently ordiscretely seal with the nose and mouth of the patient, respectively.

A positioning and stabilizing structure may be connected to the sealingportion and is adapted to engage the sealing portion with the patient.The positioning and stabilizing structure may have an upper portion anda lower portion that is constructed and arranged to avoid the patient'seyes and ears in use. The upper and lower portions may be integratedwith one another, in separate pieces that do not connect with oneanother, or in separate pieces that are coupled to one another. Thepositioning and stabilizing structure may have a rear portion adapted toengage with the back of a patient's head in use. The rear portion mayinterconnect the upper and lower portions.

The air delivery system may connect the sealing portion to a flowgenerator. The air delivery system may include an elbow and/or a tube.

The mask system provides patients with options for therapy (nares only,mouth only or nares and mouth therapy) without the system becoming tooexpensive and also improving intuitive use of the mask system. Thisallows the patient to use the mask system without too much or anyinstruction.

The mask system may be a modular mask system having the nares portionand the mouth portion, where the nares portion is adapted to be utilizedwithout the mouth portion to provide respiratory therapy to a patient'snares, or the nares portion may be adapted to be utilized with the mouthportion to provide respiratory therapy to the patient's nares and mouth,or to provide respiratory therapy to the patient's nares and to utilizethe mouth portion as a mouth seal.

The mask system may be a modular mask system having the nares portionand the mouth portion, where the mouth portion is adapted to be utilizedwithout the nares portion to provide respiratory therapy to a patient'smouth, or the mouth portion is adapted to be utilized with the naresportion to provide respiratory therapy to the patient's nares and mouth,or to provide respiratory therapy to the patient's mouth and to utilizethe nares portion as a nares seal.

The mask system may be an integrated mask system having a nares portionand a mouth portion, where the nares portion and the mouth portion areintegrated and formed in a single piece. Pressurized gas may be providedto the nares and mouth portions for delivery to the nose and mouth, orpressurized gas may be delivered only to the nares or mouth portion,with the other portion being blocked off from the pressurized gas.

As illustrated in FIGS. 1-1 to 4 , for example, a mask system 1 mayinclude a nares portion 20, a mouth portion 40 and positioning andstabilizing structure, which may include headgear 60. An air deliverysystem may deliver air to the mask system 1, such as through flexibletube 5. The mask system of FIGS. 1-1 to 4 is a modular mask system inwhich the nares portion 20 and the mouth portion 40 are both adapted tobe used without each other (in a nares only mode or in a mouth onlymode), or the nares portion 20 and the mouth portion 40 may be utilizedtogether (in a nares and mouth mode). When utilized in the nares andmouth mode, one of the nares portion 20 and the mouth portion 40 may beutilized to deliver pressurized gas, while the other of the naresportion 20 and the mouth portion 40 may be utilized as a nares or mouthseal. In another form, when utilized in the nares and mouth mode, boththe nares portion 20 and the mouth portion 40 may be utilized to deliverpressurized gas to the patient's airways. Alternatively, the mask system1 may be formed as an integrated mask system, where the nares portion 20and the mouth portion 40 are formed as a single element.

FIGS. 5-1 to 13 illustrate another mask system 1 that may be in the formof a modular mask, where the nares portion 20 and the mouth portion 40may be adapted to be used without each other, or the nares portion 20and the mouth portion 40 may be adapted to function together to deliverthe breathable, pressurized gas to the patient's nares and mouth. InFIGS. 5-1 and 6 to 13 , the flexible tube 5 is connected to the swivelring 4 via the elbow 2, to direct the pressurized, breathable gas to thechamber of the mouth portion 40 and to the nares portion 20. FIG. 5-1and FIGS. 6 to 12 illustrate the modular mask system 1 in a nares andmouth mode, where the nares portion 20 and the mouth portion 40 are bothutilized. FIG. 5-2 illustrates the mask system 1 in a nares only mode,where the nares portion 20 is used without the mouth portion 40. In thenares only mode, the elbow 2, flexible tube 5 and the swivel ring 4 areconnected to an opening in the nares portion 20.

FIGS. 14 and 15 illustrate an integrated mask system 101, which includesa nares portion 120, a mouth portion 140, and positioning andstabilizing structure, which may include headgear 160. In the integratedmask system, the nares portion 120 and the mouth portion 140 are notseparable, and are typically formed together in a single piece. An airdelivery system may deliver air to the mask system 101, such as throughand a flexible tube 105 connected to the mouth portion 140 via an elbow102.

FIGS. 16-18 illustrate another mask system 201, which may be anintegrated mask system, and which includes a nares portion 220 and amouth portion 240. An air delivery system may deliver air to the masksystem 201.

FIGS. 21 and 22 illustrate a modular mask system 301 in accordance withan embodiment of the present technology. The mask system 301 includes anares portion 320, a mouth portion 340 and headgear 360. An air deliverysystem may deliver air to the mask system 301, such as through flexibletube 305 connected to the mouth portion 340 or nares portion 320 viaconnector 306 and optional swivel connector 308. The connector 306 maybe in the form of an elbow or other type of connector. The connector 306may be a flexible portion that is able to absorb external forces thatmay otherwise dislodge the seal of nares portion 320 and/or mouthportion 340 with the patient, for example as may be caused by tube dragforces. FIG. 21 illustrates the mask system 301 in the nares only mode,and FIG. 22 illustrates the mask system 301 in the nares and mouth mode.

FIG. 23 illustrates a modular mask system 370 in accordance with anembodiment of the present technology. The mask system 370 includes anares portion 372, a mouth portion 380, and headgear 360. An airdelivery system including an air delivery tube or conduit 379 maydeliver air to the mask system 370. Further, tube 379 may function asheadgear in addition to being an air delivery tube or conduit.

FIG. 24 illustrates a modular mask system 401 in accordance with anembodiment of the present technology. The mask system 401 includes anares portion 420, a mouth portion 440, and headgear 460. An airdelivery system may deliver air to the mask system 401, such as througha flexible tube 405 connected to the mouth portion 440 via connector 402and optional swivel connector 444.

FIG. 25 illustrates an integrated mask system 501 in accordance with anembodiment of the present technology. The mask system 501 includes anares portion 520, a mouth portion 540, and headgear 560. An airdelivery system may deliver air to the mask system 501, such as througha flexible tube 505 connected to the mouth portion 540 via connector 502and optional swivel connector 544.

FIG. 34 illustrates mask system 701 that may be in the form of a modularmask, where the nares portion 720 and the mouth portion 740 may beadapted to be used without each other, or the nares portion 720 and themouth portion 740 function together to deliver the breathable,pressurized gas to the patient's nares and mouth. FIG. 34 illustratesthe mask system 701 utilized in the nares and mouth mode, with theflexible tube 705 connected to the swivel rings 710 and 744 via thedouble elbow 712, to direct the pressurized, breathable gas to thechamber of the mouth portion 740 and to the nares portion 720.

In a nares only mode, only the nares portion 720 is utilized and themouth portion 740 is not utilized. In this mode, the double elbow 712 isremoved and the mouth portion 740 is removed. The patient utilizes thenares portion 720 only, and connects the tube 705 to the swivel ring orother connector 710. An elbow such as elbow 2 may be utilized to connectthe tube 705 to the swivel ring or other connector 710.

In a mouth only mode, only the mouth portion 740 is utilized and thenares portion 720 is not utilized. In this mode, the double elbow 712 isremoved and the nares portion 720 is removed. The patient utilizes themouth portion 740 only, and connects the tube 705 to the swivel ring orother connector 744. An elbow such as elbow 2 may be utilized to connectthe tube 705 to the swivel ring or other connector 744.

1.1 Nares Portion

The nares portion is intended to form a seal with the patient's nasalairway in use. The nares portion could be a seal that is disposed on theoutside of the patient's nose, for example a cradle type mask or atypical nasal mask. Alternatively, it could be an around the nares typeseal like a pillows type mask, or it could be an in the nose type seallike nasal plugs. A nares seal may be an appropriate choice forpatient's who have upper airway obstructions. Breathing through the nosemay also have other benefits like a natural filtration of the inhaledair.

As illustrated in FIGS. 1-1 to 4 , the modular mask system 1 may includea nares portion 20. The nares portion 20 may include nares sealingportion 22, a decoupling portion 25, headgear connectors 21, a swivelring 4, and a plug 3. The headgear connectors 21 may include headgeartabs 31 adapted to connect to headgear.

The decoupling portion 25 may function to decouple forces applied to thenares portion 20 from the nares sealing portion 22, such as tube dragforces applied at the swivel ring 4 by movement of flexible tube 5. Theswivel ring 4 fits into an opening in the decoupling portion 25 on afront of the nares portion 20. The decoupling portion 25 may comprise athin walled section, for example less than 1 mm to enable flexibility ofthis portion.

The plug 3 is adapted to fit into the swivel ring. The plug 3 mayinclude a plurality of optional vent holes 6 that allow air exhaled bythe patient's nose to be vented out of the nares portion 20. Preferably,vent holes 6 are arranged in a diffuse array to prevent jetting of airfrom the vent. In some embodiments, the plug 3 may be removed andreplaced with a connection to the tube 5.

FIG. 1.1 illustrates the nares portion 20 of mask system 1 utilized in anares only mode. Nares portion 20 is utilized without mouth portion 40,and the elbow 2 and flexible tube 5 are connected to the swivel ring 4on the nares portion 20.

The nares portion 20 illustrated in FIGS. 1-1 to 4 may be a modifiedversion of the commercially sold Swift™ FX by ResMed Ltd, (e.g., asdescribed in WO 2009/052560 A1 and WO 2010/139014 A1, both of which areincorporated by reference herein in their entirety), for example,although other nares portions may be utilized. The nares portion 20 maybe modified from the commercially sold Swift™ FX by ResMed Ltd. toinclude a connector 30, as illustrated in FIGS. 1-1, 1-5 and 3 , theconnector 30 adapted to connect a chamber 49 of the nares portion 20 atan opening 46 in mouth portion 40, so that air is pneumatically allowedto flow between the nares portion 20 and the mouth portion 40. When usedin the nares only configuration as illustrated FIG. 1-1 , the connector30 is removed from the opening 46 as shown in the exploded view of FIG.1-5 , and the connector 30 is engaged with plug 35. The plug 35 isshaped so as to fit into either the opening 46 or the connector 30 asneeded. The plug 3 is removed from the nares portion 20, and the elbow 2and flexible tube 5 may be connected via the swivel ring 4 to the naresportion 20 to deliver the pressurized breathable gas to the naresportion 20.

FIGS. 5-1 to 13 illustrate a mask system 1 that includes a nares portion20. The nares portion 20 may include nares sealing portion 22, adecoupling portion 25, headgear connectors 21, and a swivel ring 4. Theheadgear connectors 21 may include headgear tabs 31 adapted to connectto headgear 60.

The nares portion 20 illustrated in FIGS. 5 to 13 may be thecommercially sold Swift™ FX by ResMed Ltd, for example, although othernares portions may be utilized. Further details of such a nares portion20 are disclosed in WO 2009/05256 A1, the disclosure of which isincorporated herein by reference in its entirety.

FIGS. 19 and 20 illustrate another nares portion 220, which may beutilized with any of the embodiments disclosed herein. The nares portion220 may include nares sealing portion 222, a support membrane 252, asupporting portion 253, and headgear connectors 230 with headgear tabs231 for connecting to headgear. The support membrane 252 may be adaptedto connect to a swivel ring or other connector for connection to asupply of pressurized, breathable gas. Further details of the naresportion 220 are disclosed in WO 2010/139014 A1, the entire contents ofwhich are incorporated herein by reference.

FIGS. 14 and 15 illustrate an integrated mask system 1, which includesthe nares portion 120. The nares portion 120 may include nares sealingportion 122, decoupling portion 125 and headgear connectors 121 adaptedto connect to headgear 160. A nares portion such as the commerciallysold Swift™ FX nares portion, the modified version of the commerciallysold Swift™ FX nares portion, or the nares portion of FIGS. 19 and 20may be utilized and integrated with the embodiment of FIGS. 14 and 15 .

FIGS. 16-18 illustrate a mask system 201 that may include nares portion220. The nares portion 220 may include nares sealing portion 222 and anorifice 226 for receiving pressurized, breathable gas. The mask system201 is illustrated with a nares portion 220 such as illustrated in FIGS.19 and 20 , although other nares portions could be utilized, such as thecommercially sold Swift™ FX nares portion or the modified version of thecommercially sold Swift™ FX nares portion.

FIGS. 21 and 22 illustrate a modular mask system 301, which includesnares portion 320. The nares portion 320 may include nares sealingportion 322, decoupling portion 325 and headgear connectors 321 forconnecting to headgear 360. Nares portion 320 may be adapted to connectto connector 306 by including opening 326 adapted to receive connector306.

FIG. 23 illustrates an integrated mask system that includes a naresportion 372 connected to a mouth portion 380 and headgear 360. The naresportion 372 includes nares sealing portion 374 adapted to form a sealwith the patient's nares.

FIG. 24 illustrates an integrated mask system 401 that includes a naresportion 420 connected to a mouth portion 440, and headgear 460. Thenares portion 420 includes nares sealing portion 422 adapted to form aseal with the patient's nares, decoupling portion 425, and headgearconnectors 421 adapted to connect to headgear 460. The nares portion 420is illustrated as the membrane type illustrated in FIGS. 19 and 20 ,although other nares portions could be utilized, such as thecommercially sold Swift™ FX nares portion or the modified version of thecommercially sold Swift™ FX nares portion.

FIG. 25 illustrates an integrated mask system 501 that includes a naresportion 520 connected to a mouth portion 540, and headgear 560. Thenares portion 520 includes nares sealing portion 522 adapted to form aseal with the patient's nares, decoupling portion 525, and headgearconnectors 521 adapted to connect to headgear 560. The nares portion 520is illustrated as the membrane type illustrated in FIGS. 19 and 20 ,although other nares portions could be utilized, such as thecommercially sold Swift™ FX nares portion or the modified version of thecommercially sold Swift™ FX nares portion.

FIG. 34 illustrates a modular mask system 701 that includes a naresportion 720 connected to a mouth portion 740, and headgear 760. Thenares portion 720 includes nares sealing portion 722 adapted to form aseal with the patient's nares, decoupling portion 725, and headgearconnectors 721 adapted to connect to headgear 760. The nares portion 720may be the commercially sold Swift™ FX nares portion, although othernares portions could be utilized, such as the commercially sold Swift™FX nares portion or the nares portion illustrated in FIGS. 19 and 20 .

FIGS. 55, 55A, 56, and 56A illustrate nares portions 1380, 1390, eachincluding foam portions 1382, 1392. The foam portions 1382, 1392 haveholes 1384, 1394 allowing passage of air to the nares of a patient. Asshown FIG. 55A, the foam portion 1382 is compliant and will reveal thenasal prong once compressed. As shown in FIG. 56A, the nasal prong rollsback to hold the foam portion 1392 in place and provide a relativelyflat surface to contact with the nose.

1.2 Mouth Portion

The mouth portion may be adapted to surround the patient's mouth andform a seal with the patient's airway at the mouth. The seal of themouth portion could be a flap type seal like a membrane type seal, or itcould be a compression seal utilizing materials such as foam, gel,fabric, etc.

A mouth portion 40 as illustrated in FIGS. 1-2 to 4 may include mouthsealing portion 42, a decoupling portion 45 to decouple forces appliedto the mouth portion 40 from the mouth sealing portion 42, lowerheadgear connectors 41, and a swivel connector 44. The mouth portion 42forms a chamber 49 into which air may be delivered and directed to thepatient's mouth.

A swivel connector 44 may be disposed in a front aperture 52 of themouth portion 40. The swivel connector 44 may be a swivel ring adaptedto connect to a tube connector, such as elbow 2, for connecting toflexible tube 5, which may deliver breathable gas to the mouth portion40. The swivel connector 44 may be removed from the front aperture ofthe mouth portion 40. Alternatively, the tube 5 may connect directly tothe mouth portion 40.

The mouth portion 40 illustrated in FIGS. 1-1 to 4 is also adapted toconnect to the nares portion 20. Specifically, the mouth portion 40, asillustrated in FIGS. 1-4 and 1-5 , may include an aperture or opening 46adapted to receive and seal with the connector 30 of the nares portion20, to pneumatically connect the nares portion 20 to the chamber 49 ofthe mouth portion 40. A plug 35 may be included with the mask system 1,the plug 35 being adapted to fit within and plug the connector 30 or theaperture 46. Also, the nares portion 20 may function in a nares modeonly without the mouth portion 40.

The mouth portion 40 may function as a docking station, where the mouthportion 40 is adapted to provide docking (the mouth portion is adaptedto removably receive the nares portion) with respect to the naresportion 20. As illustrated in FIG. 1-5 , the mouth portion may include anares portion docking station 56 formed on the mouth portion 40, wherethe nares portion docking station 56 is adapted to receive a naresportion 20. The received nares portion 20 is capable of functioning as anares only device for delivering pressurized breathable gas to the naresof a patient.

The nares portion docking station 56 may be adapted to receive the naresportion 20 by having a shape selected to mate with a shape of the naresportion. For example, as shown in FIG. 1-5 , the nares portion dockingstation may have a curved upper surface to match a curved lower of themouth portion 40. The nares portion docking station 56 may be adapted toreceive the nares portion 20 by having an opening or aperture, such asaperture 46, adapted to receive a protrusion or connector in the naresportion 20, such as connector 30. Alternative connections of the dockingstation 56 to the nares portion 20 are possible, such as utilizingundercuts or grooves to hold the nares portion 20 in place. A plug 35may be provided, the plug 35 adapted to plug either the connector 30 orthe opening 46.

When the connector 30 of the nares portion 20 is connected to theaperture 46 of the mouth portion, the plug 35 may be placed in theconnector 30 to prevent air from pneumatically flowing between the naresportion 20 and the mouth portion 40. The mouth portion 20 mayalternatively be adapted to prevent air from pneumatically flowingbetween the nares portion 20 and the mouth portion 40, by including avalve 55 as illustrated in FIG. 3 , the valve 55 selectively opening andclosing the opening 46. The patient can selectively operate the valve55, such as by turning a knob 54 illustrated in FIGS. 2 and 3 .

In some embodiments, such as illustrated in FIG. 1-3 , the elbow 2 andflexible tube 5 may not be connected to the swivel connector 44, but mayinstead be replaced with plug 3, which may or may not include theoptional vent holes 6.

FIGS. 5-1 to 13 illustrate a modular mask system 1 which includes amouth portion 40 that includes an alternative connection to naresportion 20. In particular, in the embodiments of FIGS. 5-1 to 13 , anares portion connector 43 is utilized to connect the mouth portion 40to the nares portion 20. The nares portion connector 43 is adapted tofit over and seal with the nares portion 20, so that the air from theflexible tube 5 may be delivered into the mouth portion 40, and throughnares portion connector 43 to the nares portion. The decoupling portion45 may decouple forces at swivel ring 4, such as tube drag forces, fromboth the sealing portion 22 of the nares portion 20 and from the sealingportion 42 of the mouth portion 40.

The sealing portion 42 of the mouth portion 40 may include a bottomportion 79, side portions 81, a top portion 85 and a neck portion 87.The bottom portion 79 may be adapted to form a seal with a patient'slower lip or chin area. The top portion 85 may be adapted to form a sealwith the patient's upper lip area. The side portions may be adapted toform a seal with the patient's face on side areas of the patient'smouth. The side portions 81 extend between the bottom portion 79 and thetop portion 85. The neck portion 87 connects the top portion 85 to thenares portion connector 43. The sealing portion 42 transitions from thetop portion 85 sweeping into the neck portion 87, with the neck portion42 being narrower than the top portion 85 to conform to the size andshape of the nares portion connector 43. By having the narrower neckportion 42, the pressure and flow of air into the sealing portion 42 maybe improved.

FIGS. 14 and 15 illustrate a mask system 101 that includes the mouthportion 140. The mouth portion 140 may include a structural portion 147,a mouth sealing portion 142, decoupling portion 145, headgear connectors141 for connecting to headgear, and vent 103, which may include one ormore vent holes or slots for venting gas exhaled by the patient. A naresportion connector 143 for connecting to the nares portion 120 may beutilized when the nares portion 120 and the mouth portion 140 are notformed as a unitary element. Flexible tube 105 may be connected to themouth portion 140 via an elbow 102. Structural portion 147 may beconstructed and arranged to stiffen the outer perimeter of the sealingportion to the shape of the sealing portion is maintained and sufficientsealing force is applied to the patient's face.

FIGS. 16 to 18 illustrate a mask system 201 that includes the mouthportion 240. The mouth portion 240 includes a mouth seal portion 242which may be in the form of a cushion for sealing with the mouth of thepatient, a frame 247, a mouth orifice 246 for receiving the pressurized,breathable air, a decoupling portion 245, and a nares connecting portion243 for connecting with the nares portion. FIG. 16 is illustrated withthe frame 247, the decoupling portion 245 and the connecting portion 243removed. Although not illustrated, the mouth portion may includeconnection to a flexible tube for delivery of the pressurized,breathable gas, such as the swivel connector, elbow and flexible tubeillustrated in other embodiments.

FIGS. 21 and 22 illustrate a modular mask system 301 that includes amouth portion 340. The mouth portion 340 includes decoupling portion345, opening 348 and connector 349. The connector 306 is adapted toconnect to either opening 326 in the nares portion 320 as illustrated inFIG. 21 or to opening 348 in the mouth portion 340 as illustrated inFIG. 22 . The connector 349 of the mouth portion is adapted to connectto opening 326 in nares portion 320, when the mask 301 is utilized in anares and mouth mode. A plug may be provided to plug the connector 349when the mask 301 is utilized in a mouth only mode.

The mask system 375 illustrated in FIG. 23 may include a mouth portion380. The mouth portion 380 may include a mouth sealing portion 375, andmay be adapted to connect to headgear 360, and to connect to naresportion 372. The mask system may include air delivery conduit or tube379 which may be integrated into the headgear. The air delivery tube 379thus eliminates the need for an elbow connected to the mouth portion380, providing a “ducted” air delivery and giving the mask system 375 amore streamlined look.

The mask system 401 illustrated in FIG. 24 includes a mouth portion 440.The mouth portion 440 includes a mouth sealing portion 442, headgearconnectors 441 for connecting to headgear 460 and a decoupling portion445. The swivel connector 444 may connect the mouth portion 440 to elbow402 and flexible hose 405, which delivers pressurized, breathable gas tothe mask system 401.

The mask system 501 illustrated in FIG. 25 includes a mouth portion 540.The mouth portion 540 includes a mouth sealing portion 542, headgearconnectors 541 for connecting to headgear 560, swivel connector 544 andfoam patient contacting portion 569. The foam may be placed around aperimeter of the mouth sealing portion 542, but optionally could beplaced only at selected portions, e.g., just at a top lip portion forcomfort. Silicone or another sealing means could be placed in the areasaround the perimeter of the mouth sealing portion 542 not containing thefoam. The mouth portion may 540 also include an optional decouplingportion 545. The swivel connector 544 may connect to elbow 502 andflexible hose 505, which delivers pressurized, breathable gas to themask system 501. The foam patient contacting portion 569 may contactwith and form a seal with the upper lip area of the patient, and thusform part of the mouth seal.

The mask system 701 illustrated in FIG. 34 includes a mouth portion 740.The mouth portion 740 may include a mouth sealing portion 742, adecoupling portion 745 and headgear connectors 741 for connecting toheadgear 760. A swivel ring or other connector 744 may also be used toconnect to flexible hose 705 via double elbow 712.

1.3 Sealing Portions

The sealing portion may consist of at least two portions: a naressealing portion and a mouth sealing portion. By providing at least anares sealing portion and a mouth sealing portion, the patient mayreceive pressurized breathable gas selectively through their nose and/ormouth.

The nares sealing portion may function independently of the mouthsealing portion. Therefore, in some embodiments, the patient may removethe mouth sealing portion by removing the mouth portion and use only thenares portion with the nares sealing portion if desired. The mouthsealing portion may function independently of the nares sealing portion.Thus, in some embodiments, the patient may remove the nares portion andthe nares sealing portion and use only the mouth portion and the mouthsealing portion.

The nares sealing portion and the mouth sealing portion may both need toform a seal with the upper lip of the patient. However, due to thelimited amount of surface area in which to position the nares sealingportion and the mouth sealing portion in the upper lip region, thevarious embodiments utilize structural elements to accomplish sealing ofboth the nares sealing portion and the mouth sealing portion in theupper lip region of the patient.

The mouth sealing portion may fit a wide range of the population. Themouth sealing portion may have a single size that fits most people.However, the mouth sealing portion may be provided in various sizes toaccommodate a wide range of the population. The mouth seal may belengthwise adjustable to accommodate the varying anthropometric range ofthe population.

The nares sealing portion may fit a wide range of the population.Preferably, the nares sealing portion may be provided in one or twosizes to accommodate a wide range of the population.

1.3.1 Nares Sealing Portion

The nares sealing portion is adapted to provide a comfortable andeffective seal with the nares of a patient.

The nares sealing portion may be in the form of pillows, prongs, amembrane seal such as a nasal cradle, and/or a nasal chamber.

The nares sealing portion may be the pillows seal such as disclosed inPCT Application No. WO 2009/052560 A1, which is incorporated herein byreference in its entirety.

Preferably the nares sealing portion may be flexible and compliant so asto conform to the shape of the patient's nose and/or nares in use.

Preferably the nares sealing portion may be constructed from a polymersuch as silicone, thermoplastic elastomer, thermoplastic urethane.Alternatively the nares seal portion may be constructed of foam, gel,fabric or other compliant material. Alternatively, the nares sealingportion may be constructed of a combination of materials such as a foamand fabric lamination, fabric and polymer combination or any othercombination of the afore mentioned materials.

As illustrated in FIGS. 1-1 to 4 , embodiments of the present technologymay include a nares sealing portion 22 in the form of a pillows orprongs type nares seal. The nares sealing portion 22 may alternativelybe a membrane type nares seal or a nasal chamber. Nares sealing portion22 is adapted to form a seal with the nares of a patient in use. Naressealing portion 22 may be positioned to sit underneath the patient'snose, and be shaped to form an effective seal.

As illustrated in FIGS. 19 and 20 , a nares portion 220 may includenares sealing portion 222, a support membrane 252, a supporting portion253, and headgear connectors 230 with headgear tabs 231 for connectingto headgear. All of the embodiments disclosed herein may use a naressealing portion in the form of the nares sealing portion 222 whenutilized with a membrane type nares portion.

The nares sealing portion 222 may include a nose tip engagement portion254, an upper lip engagement portion 256, and thickened corner regions258. The supporting portion 253 may include rear thickened portions 262and front thickened portions 260. A higher stiffness material inportions of the supporting portion 253 may be used instead of or inaddition to the thickened portions 260 and 262 to provide additionalsupport in these areas. The front thickened portions 260 are positionedadjacent to an area of the sealing portion that contacts with sides ofthe patient's nose in use, and transfer headgear load into a pinch forceon the sides of a patient's nose to provide an effective seal. The frontthickened portion 260 may have a thickness that increases from a top toa bottom. The rear thickened portions 262 may include a lower portion266 having a first thickness and an upper portion 264 having a secondthickness greater than the first thickness.

The nose tip engagement portion 254 is formed as a hanging, flexiblemembrane. The sides of the sealing portion 222 are connected to orbonded to the supporting portion 253, while there is a front gap betweena central portion of the sealing portion 222 and the supporting portion253 between front anchor points 257. By utilizing this hanging, flexiblemembrane, the nose tip engagement portion 254 provides a flexiblesurface that remains in tensile contact with the nose during patientinterface movement, and better accommodates varying nose geometries. Thenose tip engagement portion 254 engages with and seals with thepatient's nose, and stretches towards the supporting portion 253. Thesides of the sealing portion 222 engage with and seal with the sides ofthe patient's nose.

The sealing portion 222 includes an upper lip engagement portion 256that engages with a patient's upper lip in use. The upper lip engagementportion 256 is formed as a hanging, flexible membrane, with a rear gapbetween the upper lip engagement portion 256 of the sealing portion 222and the supporting portion 253. The rear gap is positioned between rearanchor points 259 that anchor the sealing portion 222 to the supportingportion 253. The flexible, hanging membrane provides a flexible surfacethat remains in tensile contact with the upper lip of the patient duringpatient interface movement, and can stretch to accommodate varyingfacial geometries by allowing movement of the upper lip engagementportion 256.

The rear thickened portions 262 may have a curved portion 268. The rearthickened portions 262 may include a cored out portion 270 to reduce abulk of the silicone and to reduce a curing time. The rear thickenedportions 262 are positioned directly below the thickened corner regions258 of the sealing portion 222, as may be seen in FIG. 20 . Whenutilized with headgear connectors such as illustrated in FIGS. 24 and 25, the rear thickened portions 262 transfer a load from the headgearconnectors to the thickened corner regions 258 and to the lower cornersof the patient's nose to aid in providing an effective seal, and whenthe headgear is tensioned, the transfer of load to the lower corners ofthe patient's nose is increased. The bending force from the headgearconnectors is transferred in use by the rear thickened portions 262 tothe thickened corner regions 258 of the sealing portion 222 to apply asealing force as an anchor force to regions of the patient's noseadjacent the nasal labial creases.

The nares sealing portion 222 is structured to extend or curve outwardlyfrom a supporting wall 221 formed in aperture 226 which defines an airpath through the nares portion 220.

Further details of the nares sealing portion 222 are disclosed in WO2010/139014 A1, which is incorporated herein by reference in itsentirety.

All of the embodiments disclosed herein may use a nares sealing portionin the form of a pillows or prongs type nares seal, a membrane typenares seal such as illustrated in FIGS. 19 and 20 , or a nasal chamber.

FIGS. 35 and 36 illustrate a nares sealing portion 820 that may beutilized to form a seal with a patient's nares to deliver pressurized,breathable gas to the patient's nares via opening 826 and inlet tube 830in a mask system. The nares sealing portion 820 may be a membrane typenares seal, such as the sealing portion 222 illustrated in FIGS. 19 and20 .

A dial 822 and rigid elements 823 are disposed on a bottom surface ofthe nares sealing portion 820. There may be four such rigid elements823, although any number could be used. The rigid elements 823 may bedisposed to extend radially from the dial 822, and the dial 822 may bedisposed around the opening 826. Turning the dial 822 rotates a beveledgear, causing the rigid elements 823 to move upwards or downwards, inturn causing the sides of the nares sealing portion 820 to move upwardsor downwards, increasing or decreasing a pinching force on the sides ofthe patient's nares in use.

1.3.2 Mouth Sealing Portion

The mouth sealing portion may be adapted to seal with the mouth of apatient. Preferably, the mouth sealing portion may be flexible andcompliant so as to conform to the shape of the patient's nose and/ornares in use. The mouth sealing portion may include a membrane that canstretch over the upper lip and chin regions of the patient, i.e. be moreflexible than the side regions of the membrane that interface with thecheeks of the patient. The cheeks or side of the mouth region are lesssensitive to pressure from the force of the mask so more force can beapplied in the cheeks or side region thereby anchoring the mouth portionover the mouth of the patient. Further, the flexibility of the upper lipand chin regions means that the mouth sealing portion is able to flexfrom a generally planar position to fit flat/pancake faces, and can alsofit pointy/angular faces by flexing into a concave position.

Preferably the mouth sealing portion may be constructed from a polymersuch as silicone, thermoplastic elastomer, or thermoplastic urethane.Alternatively the mouth seal portion may be constructed of a foam, gel,fabric or other compliant material. Alternatively, the mouth sealportion may be constructed of a combination of materials such as a foamand fabric lamination, fabric and polymer combination or any othercombination of the afore mentioned materials.

As illustrated in FIGS. 1-1 to 4 , embodiments of the present technologymay include a mouth sealing portion 42. Mouth sealing portion 42 isadapted to form a seal with the mouth of a patient in use. Mouth sealingportion 42 may be positioned to sit around the patient's mouth, and beshaped to form an effective seal. The mouth sealing portion 42 may be inthe form of a cushion, which forms a rear opening 50 for insertion ofthe patient's mouth. The cushion may be a soft silicone cushion, whichcontacts with the patient's mouth area and forms a seal. All of theembodiments disclosed herein may include a mouth sealing portion asdescribed above.

As illustrated in the schematic cross-sectional view of FIG. 26 , themouth sealing portion 42 may seal with the patient around the patient'smouth, in the areas of the patient's upper lip and an area between thepatient's lower lip and the patient's chin. As further illustrated inFIG. 26 , the mouth sealing portion 42 may be disposed between thedecoupling portion 25 and the patient's upper lip.

Most preferably, the mouth sealing portion may be constructed of a flapseal, such as the one disclosed in U.S. Pat. No. 7,658,189, which isincorporated herein by reference in its entirety. The mouth sealingportion may be constructed of a dual wall seal or a single wall seal.

1.3.3 Decoupling

There may be a decoupling or force absorbing element positioned as partof the nares portion or the mouth portion. A decoupling element may bepositioned between a first portion of the nares portion and a secondportion of the nares portion, and/or between a first portion of themouth portion and a second portion of the mouth portion, to preventmovement or forces acting on a the nares or mouth portions fromdisrupting the seal of the respective sealing portions.

In an embodiment, the decoupling element may be a spring. In anotherembodiment, the decoupling element may be a gusset or flexible chamber.

As illustrated in FIGS. 1-4 , a decoupling portion 25 may be disposedbetween the nares seal portion 22 and the swivel ring 4. The decouplingportion 25 may be a thin, flexible region of elastic material adapted toabsorb force and/or movement by flexing and/or altering its shape. Forexample, the decoupling portion 25 decouples forces or movement actingon the swivel ring 4 from being transferred to the nares sealing portion22.

Mouth sealing portion 40 may also include a decoupling portion 45 thatmay be disposed between the frame 47 and swivel connector 44. Thedecoupling portion 45 may be a thin, flexible region adapted to absorbforce and/or movement by flexing and/or altering its shape. For example,the decoupling portion 45 decouples forces or movement acting on theflexible tube 5, swivel connector 44, and/or the elbow 2 from beingtransferred to the mouth sealing portion 42, such as tube drag forces,providing a more effective seal with the patient. All of the embodimentsdisclosed herein may include one or more decoupling portions asdescribed that may be part of the nares portion and/or the mouthportion.

In the mask system 1180 of FIG. 46 , the nares portion 1190 is decoupledfrom movement in the mouth portion 1182 by decoupling portion 1181. Thedecoupling portion 1181 allows the nares portion 1190 to remain insealing engagement with the patient's nares if the air hose 1185 and/ormouth portion 1182 move. The nares portion 1190 may rotate relative tothe mouth portion 1182. The covering flap 1183 will move with the airhose 1185 and/or mouth portion 1182.

1.3.4 Relationship Between Nares and Mouth Sealing Portions

The sealing portion may be constructed in one piece, with the one pieceincluding the nares sealing portion and the mouth sealing portion.

The sealing portion may be constructed in more than one piece and thenmay be joined together to operate as a nose and mouth mask. For example,the nares sealing portion may be constructed in a first piece and themouth sealing portion may be constructed in a second piece, and thefirst and second pieces may then be joined together.

In a further preferred embodiment, the sealing portions may beconstructed in more than one piece, where each piece can be usedindependently of the other pieces or joined to the other pieces, eacharrangement still providing treatment to the patient. For example, thenares portion including the nares sealing portion may be separate fromthe mouth portion including the mouth sealing portion, and the naresportion including the nares sealing portion can be used without themouth portion including the mouth sealing portion attached yet still beable to deliver treatment to the patient's nares.

1.3.5 Connection of Nares and Mouth Portions to Headgear

The headgear 60 can connect to each of the nares portion 20 and themouth portion 40. This is unlike many prior art arrangements where theheadgear connects to the mouth portion only and the mouth portion isstructured and arranged to adapt the nares portion into sealingengagement with the patient's nose.

As illustrated in FIGS. 1-1 to 13 , the nares portion 20 may includeheadgear connectors 21. The headgear connectors 21 may include headgeartabs 31 that may interface or connect with apertures 62 which may be inthe form of a slot or loop on the headgear strap 61.

The mouth portion 40 may include a lower headgear connector 41 forreceiving a locking device 64 from lower headgear strap 63.

Alternative connecting devices are possible for the nares portion 20 andthe mouth portion 40. For example, hook and loop type connections, pushfit connections, interference fits, ball and socket joints, etc. may beused.

1.4 Positioning and Stabilizing Structure

The positioning and stabilizing structure in the form of headgear 60 maybe adapted to maintain the mask system in sealing engagement with thenares and mouth of a patient. The headgear 60 may include straps adaptedto secure the position of the headgear 60 on the head of the patient.The straps may include a side strap headgear strap 61, a lower headgearstrap 63, a rear headgear portion 65 and a crown headgear portion 66.The straps may also direct a tension force on the mask adapted to sealthe mask with the face of the patient.

1.4.1 Headgear Side Portion

FIGS. 1-1 to 1-3 and 5-1 to 7 show a headgear 60 in use. Side headgearstraps 61 may be adapted to be positioned over the cheeks, underneaththe eyes and above the ears of the patient. Side headgear straps 61 maybe connected to the headgear connectors 21 of the nares portion 20.

Side headgear straps 61 may include side headgear connectors 62 forconnection with the headgear connectors 21 of the nares portion 20. Sideheadgear connectors 62 may be in the form of a loop for capturing on theheadgear tabs 31 on the nares portion 20. Any connection method may bepossible, for example hook and loop connection, clips, push fit tabs.Alternatively, side headgear straps 61 may be integrally formed withnares portion 20.

Side headgear straps 61 may preferably be constructed of a flexiblematerial that may be lengthwise stretchable. Side strap 61 may beconstructed of a fabric, foam, foam and fabric composition, silicone,nylon, elastic, or any other flexible material.

Side headgear straps 61 may provide an upwards vector to the mask system1 to assist in maintaining the mask system 1 in the desired position.The upwards vector may be angled upwards with respect to a vectorapplied by the lower headgear strap 63.

1.4.2 Headgear Crown Portion

Headgear 60 may further include a crown strap portion or top strap 66that may be adapted to be positioned in use over the top or crown of thepatient's head. Crown strap portion 66 may provide an upwards vector tothe mask system to assist in maintaining the mask system in the desiredposition.

Crown strap portion 66 may be continuous with or otherwise connected toside headgear strap 61. Crown strap portion 66 and/or side headgearstrap 61 may further include strap loop 68. Strap loop 68 may bestructured to receive a rear portion 65.

Crown strap portion 66 may further include adjustment mechanism 69.Adjustment mechanism 69 may be that described in WO 2009/052560 A1,which is incorporated herein by reference in its entirety.

Crown strap portion 66 may preferably be constructed of a flexiblematerial that may be lengthwise stretchable. Crown strap portion 66 maybe constructed of a fabric, foam, foam and fabric composition, silicone,nylon, elastic, or any other flexible material.

1.4.3 Headgear Lower Portion

Headgear 60 may further include lower headgear strap 63, which mayconnect to the mouth portion 40 of the mask system 1. Lower headgearstrap 63 may direct a tension force on the mouth portion 40 to provide avector force normal to the patient's face and hence sealing of the mouthportion 40 on the patient's face.

Lower headgear strap 63 may be a strap that is directed substantiallyunder the ears of the patient.

Lower headgear strap 63 may connect or be otherwise formed with headgearrear portion 65.

1.4.4 Headgear Rear Portion

Headgear 60 may further include a rear portion or strap 65. Rear portion65 may be continuous with or otherwise attached to side headgear strap61 or crown strap portion 66. Rear portion 65 may be threaded throughstrap loop 68, and positioned above the ears of the patient. Rearportion 65 may travel down the sides of the patient's head in use andcapture the occiput to anchor the headgear 60 in position. Rear portion65 may further attach to a lower headgear strap 63 at connecting region67.

Rear portion 65 may provide a downwards and rearwards (i.e. away fromthe patient's face) vector to balance the upwards vector of the crownstrap portion 66, and assist in pulling the mask system 1 into sealingengagement with the patient's face.

Rear portion 65 may be secured in position under the patient's occiputby attachment to a lower strap 63 (see FIG. 7 ). Attachment may be atconnection region 67. Connection region 67 may comprise a stitched join,hook and loop join or any other join. Connection region 67 may also be apermanent join such that rear portion 65 and lower strap 63 are formedin one piece.

Rear portion 65 may preferably be constructed of a flexible materialthat may be lengthwise stretchable. Rear portion 65 may be constructedof a fabric, foam, foam and fabric composition, silicone, nylon,elastic, or any other flexible material.

1.4.5 Headgear Options

The various mask system and kit embodiments may include various headgearoptions such as illustrated in FIG. 33 . For example, when utilized in anares only mode, nares portion headgear 812 adapted to secure the naresportion to the patient's head may be utilized. When utilized in a mouthonly mode, mouth portion headgear 850 adapted to secure the mouthportion to the patient's head may be utilized.

The nares portion headgear 812 utilizes headgear vectors that are angledupwards to align the nares sealing force with the patient's nares. Themouth portion headgear 850 utilizes headgear vectors that are generallyoriented in the horizontal plane to align the mouth sealing force withthe patient's mouth. The headgear vectors are angled relative to oneanother in the examples shown in FIG. 33 and FIGS. 37-38 . However, inthe examples of FIGS. 40-41 , the headgear vectors are generallyparallel to one another due to the nature of the cushion and the sealingforces involved.

When utilized in a nares and mouth mode, nares portion headgear 812 andmouth portion headgear 850 may be utilized together to secure the naresportion and the mouth portion to the patient's head. Alternatively,nares and mouth portion headgear 860 may be utilized, which includes aconnection region in the back portion, such as connection region 67illustrated in FIG. 7 . The nares and mouth portion headgear 860 createsheadgear vectors that go back and up along the patient's head to securethe nares portion 820 to the patient's nares, and that go back along thepatient's head to secure the mouth portion 840 to the patient's head.

Also, connected nares and mouth portion headgear 870 may be utilized,which includes a connector 856 for connecting the nares only headgearand the mouth only headgear at a back portion. The connector 856 may bea Velcro connector, a hook or loop material connector, or the like. Anyof the above described headgear options may be utilized with the variousembodiments.

Other alternatives for allowing selective attachment and detachment arepossible, see, e.g., FIG. 66 described below, which includes a back loop1622 through which the back strap 1699 extends.

Another variant is shown in FIGS. 90 and 91 which show another optionfor converting from a two point headgear to a four point headgear. Theheadgear 2000 includes the two point headgear 2001 as shown in FIG. 33and FIG. 66 , including a pair of front straps to support the mask. Inaddition, the rear of the headgear 2000 includes the first rear strap2002 connected to the pair of front straps and a second rear strap 2006that may be connected to the first rear strap, e.g., by a press studarrangement or snaps. In particular, the first rear strap 2002 may havea male part 2002.1, and the second rear strap 2006 may have acomplementary/female part 2006.2, to allow selected attachment anddetachment.

1.5 Vent

Embodiments of the present technology may utilize one or more vents inthe mask system to vent gas exhaled by the patient. The vent or ventsmay be disposed to vent exhaled gas from the nares portion 20, from themouth portion 40 or from the nares portion 20 and the mouth portion 40.

For example, a plug 3 is included on nares portion 20 and may include avent 6 to vent exhaled gas from the patient's nares. Another vent 6 mayoptionally be included on the elbow 2 connected to the mouth portion 40,to vent exhaled gas from the patient's mouth. Either of the vents 6 maybe excluded, particularly if one of the nares portion 20 or the mouthportion 40 is to be used as a sealed portion, e.g., a portion notdelivering breathable gas to the patient.

The vents 6 may be in the form of a series or array of individual ventholes. Alternatively, the vent 6 may be in the form of one or a seriesof slots, such as illustrated in FIGS. 5 and 6 , or another aperture orapertures.

1.6 Air Delivery System

Air delivery in the form of pressurized, breathable gas is delivered tothe mask system 1 through the flexible tube 5. The flexible tube 5 iscoupled to a blower/humidifier or other air delivery device, which isadapted to deliver the pressurized, breathable gas to the patient toprovide therapy.

1.7 Modular Mask System

The mask system embodiments disclosed herein may be modular masksystems, including a nares portion, a mouth portion and headgear. Themodular mask systems may be adapted to allow a patient to selectivelyutilize the nares portion and/or the mouth portion in a first mode andin a second mode. In the first mode, the patient may utilize both thenares portion and the mouth portion. In the second mode, the patient mayutilize only the nares portion without utilizing the mouth portion.

Some of the embodiments may also allow the modular mask system to beutilized in a third mode, where the mouth portion is utilized, and thenares portion is not utilized. In embodiments that provide the thirdmode, the mouth portion is utilized to provide air to the patient'smouth, while the nares portion is not utilized and not worn by the user.In addition, in some embodiments, the nares portion and the mouthportion may be adapted to allow air to freely flow between the chambersof the nares portion and the mouth portion, such as an opening and/or aconnector between the chambers. Some embodiments may include a plug or aselectively operated valve that may be used to plug the opening orconnector to prevent air from flowing between the nares portion and themouth portion. The plug may also be used to plug the opening orconnector when the nares portion or the mouth portions are used alone.All of the modular mask systems may alternatively be formed asintegrated mask systems, where the nares portions are not separable andindividually useable from the mouth portions.

FIGS. 32(a) to 32(k) are schematic illustrations of a nares portion 20and a mouth portion 40 utilized with the various modes. In the firstmode, the patient may utilize both the nares portion and the mouthportion, as illustrated in FIGS. 32(e), 32(f), 32(g), 32(h) and 32(k),by utilizing the nares portion 20 to deliver air to the patient's nareswhile utilizing the mouth portion 40 to deliver air to the patient'smouth. In FIG. 32(e), the nares portion 20 and the mouth portion 40 donot include a connection between the chambers of the nares portion andthe mouth portion, and the pressurized air is applied separately to boththe nares portion 20, which delivers the air to the patient's nares, andto the mouth portion 40, which delivers the air to the patient's mouth.In FIG. 32(f), there is a connection between the chambers of the naresportion 20 and the mouth portion 40. The pressurized air is applied tothe chamber of the mouth portion 40, and flows through the mouth portion40 to the patient's mouth, and flows from the mouth portion 40 throughthe connection to the nares portion 20 and to the patient's nares.

In FIG. 32(g), there is a connection between the chambers of the naresportion 20 and the mouth portion 40. The pressurized air is applied tothe chamber of the nares portion 20, and flows through the nares portion20 to the patient's nares, and flows from the nares portion 20 throughthe connection to the mouth portion 40 and to the patient's mouth. InFIG. 32(h), there is a connection between the chambers of the naresportion 20 and the mouth portion 40. The pressurized air is applied tothe chamber of the nares portion 20 and to the chamber of the mouthportion 40, and may flow through the connection between the naresportion 20 and the mouth portion 40. In FIG. 32(k), there is aconnection between the chambers of the nares portion 20 and the mouthportion 40, but the connection is blocked by a plug, a valve or thelike. The pressurized air is applied to the chamber of the nares portion20 and to the chamber of the mouth portion 40, and flows through thenares portion 20 to the patient's nares and through the mouth portion 40to the patient's mouth.

In the first mode, the patient may also utilize both the nares portion20 and the mouth portion 40, as illustrated in FIGS. 32(c) and 32(i) byutilizing the nares portion 20 as a nares seal while utilizing the mouthportion 40 to deliver air to the patient's mouth. In FIG. 32(c), thereis no connection between the nares portion 20 and the mouth portion 40,and the pressurized air is delivered through the mouth portion 40 to thepatient's mouth, while the nares portion is utilized as a nares seal. InFIG. 32(i), there is a connection between the nares portion 20 and themouth portion 40, but the connection is blocked by a plug, a valve orthe like. The pressurized air is delivered through the mouth portion 40to the patient's mouth, and the nares portion 20 is utilized as a naresseal.

In the first mode, the patient may utilize both the nares portion 20 andthe mouth portion 40, as illustrated in FIGS. 32(d) and 32(j), byutilizing the nares portion 20 to deliver air to the patient's nareswhile utilizing the mouth portion 40 as a mouth seal. In FIG. 32(d),there is no connection between the nares portion 20 and the mouthportion 40, and the pressurized air is delivered through the naresportion 20 to the patient's mouth, while the mouth portion 40 isutilized as a mouth seal.

In the second mode, as illustrated in FIG. 32(a), the nares portion 20is used alone to deliver air to the patient's nares, while the mouthportion is not used and is not worn by the patient. In embodiments thatutilize a connection allowing air to flow between the nares portion andthe mouth portion, when the nares portion 20 is utilized alone, a plug,a valve or the like may be utilized to plug the opening.

In the third mode, as illustrated in FIG. 32(b), the mouth portion 40 isused alone to deliver air to the patient's mouth, while the naresportion 20 is not used and is not worn by the patient. In embodimentsthat utilize a connection allowing air to flow between the nares portion20 and the mouth portion 40, when the mouth portion 40 is utilizedalone, a plug, a valve or the like may be utilized to plug the opening.

The embodiment of FIGS. 1-1 to 4 is a modular mask system 1, where thenares portion 20 may be used by a patient in a nares only mode withoutthe mouth portion 40, the mouth portion 40 may be utilized by a patientin a mouth only mode without the nares portion 20, and the nares portion20 may be utilized with the mouth portion 40 in a nares and mouth mode.FIGS. 1-2 and FIGS. 2 to 4 illustrate the mask system 1 in a nares andmouth mode where the nares portion 20 is utilized with the mouth portion40. When utilized in the nares and mouth mode, the mask system 1 mayutilize the nares portion 20 to deliver air to the nares of a patientand the mouth portion 40 to deliver air to the mouth of the patient, themask system 1 may utilize the nares portion 20 to deliver air to thenares of a patient and the mouth portion 40 may be utilized as a mouthseal that does not deliver air to the mouth of the patient, or the masksystem 1 may utilize the mouth portion 40 to deliver air to the mouth ofthe patient and the nares portion 20 may be utilized as a nares sealthat does not deliver air to the nares of the patient.

Both the nares portion 20 and the mouth portion 40 are adapted toconnect to a source of the pressurized, breathable gas. In particular,in the embodiments of FIGS. 1-2 to 4 , both the nares portion 20 and themouth portion 40 are adapted to connect to a source of the pressurized,breathable gas, such as flexible tube 5 via elbow 2, although only oneof the portions may be connected. The flexible tube 5 may be connectedto either or both of the nares portion 20 and the mouth portion 40. Aconnection to both the nares portion 20 and the mouth portion 40 may bemade by utilizing a connector such as double elbow 712 illustrated inFIG. 34 , for example.

In the embodiments of FIGS. 1-2 and FIGS. 2 to 4 , the nares portion 20and mouth portion 40 are internally connected allowing air to flowtherebetween, such as by utilizing the connector 30 in the nares portionconnected to the opening 46 in the mouth portion 40, although otherconnections could be used. If it is desired to prevent the air flowingbetween the nares portion 20 and the mouth portion 40, the connectionmay be block by using the plug 35 or the valve 55 activated by the knob54.

The mask system 1 may be utilized where the pressurized, breathable gasis received by the patient's nares and mouth by connecting the elbow 2and flexible tube 5 to either of the swivel connector 4 of the naresportion 20 or the swivel connector 44 of the mouth portion 40, and thebreathable gas can flow through the connector 30 and opening 46. Themask system 1 can also function as a mouth seal or nares seal, where theconnector 30 and/or opening 46 would be blocked, by utilizing plug 35,or by activating the valve with the knob 54, and connecting only one ofthe nares portion 20 or the mouth portion 40 to the elbow 2 and flexibletube 5. For example, if the elbow 2 and flexible tube 5 are connected tothe nares portion 20, and the connector 30 and/or opening 46 are blockedby utilizing plug 35 or by activating the valve 55 with the knob 54,then the pressurized air is delivered to the nares portion 20 and themouth portion 40 acts as a mouth seal that does not deliver thepressurized air to the patient's mouth. Alternatively, if the elbow 2and flexible tube 5 are connected to the mouth portion 40, and theconnector 30 and/or opening 46 are blocked by utilizing plug 35 or byactivating the valve 55 with the knob 54, then the pressurized air isdelivered to the mouth portion 40 and the nares portion 20 acts as anares seal that does not deliver the pressurized air to the patient'snares.

The mask system 1 is also adapted to function in a nares only modeutilizing the nares portion 20 without the mouth portion 40, asillustrated in FIG. 1-1 . In this mode, the mouth portion 40 andheadgear 63 are not utilized, the plug 3 is removed from the naresportion 20, and the elbow 2 and the flexible tube 5 are connected to thenares portion 20 to deliver the pressurized, breathable gas to thepatient's nares. The connector 30 is plugged with plug 35.

The mask system 1 is also adapted to function in a mouth only modeutilizing the mouth portion 40 without the nares portion 20, asillustrated in FIG. 1-4 . In this mode, the nares portion 20 along withthe headgear 61 are not utilized, and the elbow 2 and the flexible tube5 are connected via the swivel connector 44 to the mouth portion 40 todeliver the pressurized, breathable gas to the patient's mouth. Theopening 46 on the mouth portion is plugged with the plug 35.

FIGS. 5-1 to 13 illustrate another embodiment of a mask system 1 thatmay be a modular mask system. FIGS. 5-1 and 6-13 illustrate the modularmask system 1 in a nares and mouth mode. The flexible tube 5 isconnected via the swivel ring 4 to the elbow 2, to direct thepressurized, breathable gas to the chamber of the mouth portion 40 andto the nares portion 20 via the nares portion connector 43.

The decoupling portion 45 is connected between the swivel ring 4 andboth the nares portion 20 and the mouth portion 40. In addition, thenares portion 20 also may include the decoupling portion 25, such thatthe nares portion benefits from two decoupling portions to decoupleforces or movements applied to the flexible tube 5, the elbow 2, and/orthe swivel ring 4 from being transferred to the sealing portion 22 ofthe nares portion 20.

In the embodiments of FIGS. 5-1 to 13 , the nares sealing portion 22 maybe in the form of nasal pillows such as illustrated in FIGS. 8, 9, 11and 12 , or may be in the form of prongs, a membrane seal such as anasal cradle, and/or a nasal chamber. For example, the nares portion ofFIGS. 5-13 may be in the form of the nares portion 220 illustrated inFIGS. 19 and 20 . The supporting portion 252 may or may not be included.When utilizing the nares portion 220, the sealing portion 222 sealingwith the patient's nares is structured to extend or curve outwardly froma supporting wall 221 defining an air path through the sealing portion222, and forms a seal with the nose tip, upper lip and nares of thepatient.

As illustrated in FIG. 5-2 , the mask system may be utilized in a naresonly mode. In this mode, the mask system is utilized with the naresportion 20, and the mouth portion 40 is not utilized by the patient. Toconvert the mask system from the nares and mouth mode to the nares onlymode, the swivel ring 4, the elbow 2 and the flexible tube 5 are removedfrom mouth portion 40, the mouth portion 40 is removed from connectionwith the nares portion 20 by disconnecting the nares portion connector43 from the nares portion 20, and the swivel ring 4, the elbow 2 and theflexible tube 5 are connected to the nares portion. While the headgear60 illustrated is shown with a connection region 67, the connectionregion 67 may be omitted to facilitate usage of the mask system 1 in thenares only configuration without the lower headgear strap 63.

FIGS. 21 and 22 illustrate a mask system 301 in accordance with anembodiment of the present technology. The mask system 301 is adapted tobe utilized in a nares only mode, in a mouth only mode, or in a naresand mouth mode. The mask system 301 includes a nares portion 320, amouth portion 340 and headgear 360, connector 306, optional swivelconnector 308 and flexible tube 305. The connector 306 may be in theform of an elbow or other type of connector.

The nares portion 320 includes nares sealing portion 322, headgearconnectors 321 for connecting to headgear 360, decoupling portion 325and opening 326. The nares sealing portion 322 may be in the form ofpillows, prongs, a nasal chamber, or a membrane seal, and may be in theform of nares sealing portion 222 illustrated in FIGS. 19 and 20 . Themouth portion 340 includes decoupling portion 345, opening 348 andconnector 349. The connector 306 is adapted to connect to either opening326 in the nares portion 320 or opening 348 in the mouth portion 340.

As illustrated in FIG. 21 , the mask system 301 is adapted to be used bya patient in a nares only mode without the mouth portion 340. Connector306 is connected to the opening 326 in the nares portion 320. Theoptional swivel connector 308 may be utilized between the connector 306and the flexible tube 305, which delivers the pressurized, breathablegas to the nares portion 320.

As illustrated in FIG. 22 , the nares only configuration of FIG. 21 maybe converted into a nares and mouth configuration by removing theconnector 306 from opening 326 in the nares portion 326, connectingconnector 349 of the mouth portion to opening 326, and connectingconnector 306 to opening 348 in the mouth portion 340. In the nares andmouth configuration, the nares portion may receive the pressurized,breathable gas through the connector 349 and the opening 326.Alternatively, the nares portion 320 may be used as a nares seal byplacing a plug in the connector 349, so that the pressurized, breathableair is not delivered to the nares portion 320.

The mouth portion 340 may also be utilized without the nares portion 320in a mouth only configuration. In the mouth only configuration, thenares portion 320 is not utilized, and a plug is placed in connector 349to provide a seal.

FIG. 24 illustrates a modular mask system 401 in accordance with anembodiment of the present technology. The mask system 401 includes anares portion 420, a mouth portion 440, and headgear 460.

The nares portion 420 includes a nares sealing portion 422 for forming aseal with the patient's nares, and headgear connectors 421 adapted toconnect to headgear 460. The nares portion 420 is illustrated with anares sealing portion 422 such as the type illustrated in FIGS. 19 and20 , although other nares sealing portions could be utilized, such aspillows, prongs, a nasal chamber, etc. An optional decoupling portion425 may be included for decoupling any forces applied to the naresportion 420. The headgear 460 may be the same as the headgear 60illustrated in FIGS. 1-1 to 4 .

The mouth portion 440 includes a mouth sealing portion 442, headgearconnectors 441 for connecting to headgear 460, and swivel connector 444.The mouth portion may also include an optional decoupling portion 445.The swivel connector 444 may connect to elbow 402 and flexible hose 405,which delivers pressurized, breathable gas to the mask system 401. Themask system 401 could alternatively be formed as a modular mask system,where the mouth portion 440 is separable from the nares portion 420 andboth portion are individually useable, and the flexible tube 405 isconnectable via the swivel connector 444 or the like to the naresportion 420. A flexible portion 443 may be disposed between thedecoupling portion 425 and the decoupling portion 445. The flexibleportion 443 may be a gusset or collapsible portion between the mouthportion 440 and the nares portion 420, which allows the nares portion420 to adopt the nasolabial angle (the angle between the septum of thenose and the top lip of the patient).

FIG. 25 illustrates a modular mask system 501 in accordance with anembodiment of the present technology. The mask system 501 includes anares portion 520, a mouth portion 540, and headgear 560.

The nares portion 520 includes nares sealing portion 522 adapted to forma seal with the nares of the patient, and headgear connectors 521 forconnecting to headgear 560. The nares portion 520 is illustrated with anares sealing portion 522 such as the type illustrated in FIGS. 19 and20 , although other nares sealing portions could be utilized, such aspillows, prongs, a nasal chamber, etc. An optional decoupling portion525 may be included for decoupling any forces applied to the naresportion 520. The headgear 560 may be the same as the headgear 60illustrated in FIGS. 1-1 to 4 .

The mouth portion 540 includes a mouth sealing portion 542, headgearconnectors 541 for connecting to headgear 560, swivel connector 544 andfoam sealing or patient contacting portion 569. The foam patientcontacting portion 569 may be a wedge utilized as at least a part of aportion of the mouth seal. The mouth portion may 540 also include anoptional decoupling portion 545. The swivel connector 544 may connect toelbow 502 and flexible hose 505, which delivers pressurized, breathablegas to the mask system 501. The mask system 501 could alternatively beformed as an integrated mask system, where the mouth portion 540 isseparable from the nares portion 520 and both portions are individuallyuseable, and the flexible tube 505 is connectable via the swivelconnector 544 or the like to the nares portion 420.

FIG. 34 illustrates another modular mask system 701. The mask system 701includes a nares portion 720, a mouth portion 740, and headgear 760. Inthis embodiment, the nares portion 720 is in a modular connection withthe mouth portion 740, so that the nares portion 720 may be utilizedwithout the mouth portion 740 in a first nares only mode, the mouthportion 740 may be utilized without the nares portion in a second mouthonly mode, or the nares portion 720 may be utilized with the mouthportion 740 in a third nares and mouth mode.

The nares portion 720 may include a sealing portion 722 adapted to forma seal with the patient's nares, an optional decoupling portion 725, andheadgear connectors 721 for connecting to headgear 760. A swivel ring orother connector 710 may also be utilized. The sealing portion 722 may bein the form of pillows, prongs, a nasal chamber or a nares sealingportion, such as the membrane type illustrated in FIGS. 19 and 20 .

The mouth portion 740 may include a mouth sealing portion 742, adecoupling portion 745 and headgear connectors 741 for connecting toheadgear 760. A swivel ring or other connector 744 may also be used.

In a mouth and nares mode such as illustrated in FIG. 34 , the naresportion 720 and the mouth portion 740 are both utilized and connected toflexible tube 705 through double elbow 712. Double elbow 712 includestwo elbow joints so that it may connect to both the nares portion 720and the mouth portion 740 to deliver the pressurized, breathable air tothe patient's nares and mouth. The nares portion 720 and the mouthportion 740 may or may not be connected pneumatically.

In a nares only mode, only the nares portion 720 is utilized and themouth portion 740 is not utilized. In this mode, the double elbow 712 isremoved and the mouth portion 740 is removed. The patient utilizes thenares portion 720 only, and connects the tube 705 to the swivel ring orother connector 710. An elbow such as elbow 2 may be utilized to connectthe tube 705 to the swivel ring or other connector 710.

In a mouth only mode, only the mouth portion 740 is utilized and thenares portion 720 is not utilized. In this mode, the double elbow 712 isremoved and the nares portion 720 is removed. The patient utilizes themouth portion 740 only, and connects the tube 705 to the swivel ring orother connector 744. An elbow such as elbow 2 may be utilized to connectthe tube 705 to the swivel ring or other connector 744.

FIG. 26 illustrates a schematic cross-section view of a mask system 1utilized in a nares and mouth mode. In this embodiment, the mouthportion 40 may include a sealing ring 51 adapted to connect and seal themouth portion 40 to the nares portion 20. Alternatively, the sealingring 51 may be formed as part of the nares portion 20 and connect andseal with the mouth portion 40. Further, other types of connectors couldbe utilized or the nares portion 20 and the mouth portion 40 could beformed as a unitary element so that a sealing ring or other type ofconnector would not be needed.

In FIG. 26 , the flexible tube 5 is connected to the mouth portion 40via a gusset 8 and an optional inline AAV (anti-asphyxia valve) adaptor10, and does not utilize the elbow 2 and swivel connector 4. Thisembodiment presents a very streamlined appearance by moving the flexibletube 5 away from the front of the patient's face.

FIG. 29-1 illustrates a schematic cross-section view of a mask system401 utilized in a nares and mouth mode. The nares portion 420 mayinclude a supporting portion 458 and a sealing portion 422. The sealingportion 422 includes a nose tip engagement portion 454 that engages andseals with the patient's nose tip, an upper lip engagement portion 456that engages and seals with the patient's upper lip area, and a sealingring 472 that engages and seals with the mouth portion 440. The sealingring 472 may optionally be part of the mouth portion 440, instead ofbeing part of the nares portion 420.

Mouth portion 440 may include swivel ring 444, which connects toflexible tube 405. The flexible tube 405 may connect directly to theswivel ring 444, or may be connected through an elbow, such as elbow402. The mouth sealing portion 442 forms a seal around the patient'smouth, and includes an upper lip engagement portion 448 that forms aseal with the patient's upper lip area.

There is a limited amount of room on the patient's upper lip for theupper lip engagement portion 456 of the nares portion 420 and for theupper lip engagement portion 448 of the mouth portion. Accordingly, theupper lip engagement portion 448 may be disposed between the supportportion 458 of the nares portion 420 and the patient's upper lip. FIG.29-2 illustrates the mouth sealing portion 442, with the upper lipengagement portion 448. The upper lip engagement portion 448 may be anultra thin flat membrane having a thickness of about 0.1 to 0.3 mm,preferably about 0.2 mm, as compared to the rest of the mouth sealingportion 442, which may have a thickness of about 0.3 to 2 mm, preferablyabout 0.5 mm. However, portions of the mouth sealing portion 442 couldinclude thickened portions 409 around the sides of the mouth regioncorresponding to a cheek area of a patient for added support. Thesethickened regions 409 could have a thickness of about 1.5 mm, forexample.

FIG. 29-3 is a schematic cross-sectional view that illustrates furtherdetails of the mask system 401. In particular, FIG. 29-3 illustrates howthe mouth sealing portion 442 extends around the mouth of the patientand how the nares flare engagement portion 427 engages with the flaresof the patient's nares. Additionally, the back edge of the nasal sealingarea 470 is illustrated along with an edge 472 of the nares sealingportion 422.

FIG. 30-1 illustrates a schematic cross-sectional view of a mask system501 utilized in a nares and mouth mode. The nares portion 520 mayinclude a supporting portion 558, a sealing portion 522 and an optionaldecoupling portion 525. The sealing portion 522 includes a nose tipengagement portion 554 that engages and seals with the patient's nosetip, and an upper lip engagement portion 556 that engages and seals withthe patient's upper lip area. A sealing ring 572 that engages and sealswith the mouth portion 540 may be attached to the decoupling portion.The sealing ring 572 may optionally be part of the mouth portion 540instead of being part of the nares portion 520.

The mouth portion 540 may include an optional cushion rigidizer 573 toincrease the rigidity of the sealing portion 522. The cushion rigidizer573 may be made from a polymer such as polycarbonate, nylon,polypropylene, high density foam, a fabric having low stretch propertieslike a 3D weave, or a higher shore hardness silicone or gel, e.g. 70Shore A. There is a limited amount of room on the patient's upper lipfor the upper lip engagement portion 556 of the nares portion and for anupper lip engagement portion of the mouth portion. Accordingly, the foampatient contacting 569 may be disposed in a gap between the cushion onthe mouth portion 540 and the upper lip engagement portion 556. The foampatient contacting 569 may contact with and form a seal with the upperlip area of the patient, and thus form part of the mouth seal.

FIG. 30-2 illustrates a schematic cross-sectional view of the masksystem 501 utilized in the second nares and mouth mode. The sealing ring572 is formed as part of the mouth portion 540 and is adapted to engageand seal with the decoupling portion 525 of the nares portion 520. Thereis a limited amount of room on the patient's upper lip for the upper lipengagement portion 556 of the nares portion and for an upper lipengagement portion of the mouth portion. In this embodiment, the foampatient contacting portion 569 is disposed against the decouplingportion 525 and the cushion on the mouth portion 540, and contacts withand forms a seal with the upper lip area of the patient. The foampatient contacting portion 569 may form part of the mouth seal. Thecushion rigidizer 573 of FIG. 30-1 may also be used in the embodiment ofFIG. 30-2 and in any of the other embodiments disclosed herein.

FIG. 42 illustrates a schematic cross-section view of a mask system 1100utilized in a nares and mouth mode. The mask system 1100 may be avariation of the mask system 701 illustrated in FIG. 34 . The masksystem 1100 includes a nares portion 1120, a mouth portion 1130, and adouble elbow 1140. A lower end 1141 of the double elbow 1140 is adaptedto connect to swivel 1105, which may be connected to a flexible tube todeliver air to the mask system 1100. Lower end 1141 may connect toswivel 1105 with a ball and socket arrangement (as shown) adapted toprovide a greater degree of movement of the swivel and therefore the airdelivery tube. Alternatively, lower end 1141 may connect to swivel 1105in any arrangement for example an interference fit, over mold, etc.

A first air passage or branch 1146 of the double elbow 1140 is adaptedto communicate with an aperture in mouth portion 1130, and a second airpassage or branch 1148 of the double elbow 1140 is adapted tocommunicate with an aperture in nares portion 1120. A first elbow ring1142 and a second elbow ring 1144 are used to connect the double elbow1140 to the nares portion 1120 and the mouth portion 1130, respectively,although other types of connectors may be utilized. The double elbow mayinclude barbed end portions 1143 on the ends of the first branch 1146and the second branch 1148 to engage with the mouth portion 1130 and thenares portion 1120.

The mouth portion 1130 includes a lower lip engagement portion 1134adapted to form a seal below the patient's lower lip, and an upper lipengagement portion 1132 adapted to form a seal just above the patient'supper lip. The nares portion 1120 includes nozzles 1122 adapted tolocate the nares portion 1120 proximal to the patient's nares and ensurethe foam portion 1154 is located in a position to sealingly engage thepatient's nares, although pillows, a nasal chamber, a nasal cradle(nares seal) or a membrane seal could also be used to form a seal withthe patient's nares.

The mouth portion 1130 may be a single wall or fabric/foam compositionmouth portion with a relatively low Shore hardness. The nares portion1120 may have a hardness of e.g., 40 Shore A.

FIG. 43 illustrates a schematic cross-section view of the mask system1100 utilized in a nares and mouth mode, and is the same as the masksystem 1100 of FIG. 42 with a different nares portion 1150. Naresportion 1150 includes a supporting portion 1153 that supports nozzles1152, and foam portion 1154. The nozzles 1152 and foam portion 1154together form a sealing portion adapted to form a seal with thepatient's nares. The nozzles 1152 may have an air passage that graduallydecreases in size as the air approaches the patient's nares. Thesupporting portion 1153 may have a hardness of e.g., 40 Shore A. Thenozzles 1152 aid in supporting the foam portion 1154 in positionproximate to the patient's nares. The foam portion 1154 enables a largerfit range as the foam is able to conform to various nares sizes due tothe compressibility of the foam. The foam portion 1154 also providescomfort to the patient.

FIG. 44 illustrates a schematic cross-section view of the mask system1100 utilized in a nares and mouth mode, with a nares portion 1160.Nares portion 1160 includes a supporting portion 1162 and a sealingportion 1164. The supporting portion 1162 may be constructed of siliconeand acts as an intermediate or connecting portion between the doubleelbow 1140 and the sealing portion 1164.

The supporting portion 1162 positions the sealing portion 1164underneath the nares of the user and maintains the sealing portion 1164in this position. The supporting portion 1162 may include substantiallyparallel side portions and end portions 1165 formed substantiallyperpendicular to the side portions. The end portions 1165 provide aninterface surface for the sealing portions 1164. The sealing portion1164 may be constructed of foam, gel or other conformable material.Preferably the sealing portion 1164 is more flexible than the supportingportion 1162 so as to aid in the comfort of the seal and the fit range.The sealing portion 1164 may be foam with an aperture, the foam forminga seal with the patient's nose tip, upper lip and nares. In an example,as shown in FIG. 44A, the supporting portion may include support walls1162-1 (e.g., constructed of silicone or a material with higherstiffness than the foam sealing portion) to prevent the foam fromcompressing and occluding the nares. In another example, as shown inFIG. 44B, the foam sealing portion 1164 may have a trumpet shape (e.g.,flare outwards) with a silicone support wall underneath to ensurestructural stability of the foam and also ensure sealing engagement withthe patient.

FIG. 45 illustrates a schematic cross-section view of the mask system1100 utilized in a nares and mouth mode, with a nares portion 1170. Thenares portion 1170 includes a supporting portion 1172 and a sealingportion 1174. The sealing portion 1174 includes a nose tip engagementportion 1176 and an upper lip engagement portion 1178. The supportingportion 1172 may form a seal just above the patient's upper lip, and maybe positioned between the patient's upper lip and the upper lipengagement portion 1132 of the mouth portion 1130.

The supporting portion 1172 may have a higher Shore hardness than thesealing portion 1174. For example, the supporting portion may have aShore A hardness of, e.g., 20-80, preferably 30-60, or about 40 whilethe sealing portion 1174 has a Shore A hardness of about 5-40 or about20. The hardness of the sealing portion is generally lower than thesupporting portion.

FIG. 46 illustrates a schematic cross-section view of a mask system 1180utilized in a nares and mouth mode, with mouth portion 1182 and a naresportion 1190. The nares portion 1190 may be removable from the masksystem 1180 and replaceable with a plug, so that the mask system 1180may be used in a mouth only mode.

The mouth portion 1182 includes an aperture for connection of an airsupply to deliver air to the mask system 1180. Elbow 1188 connects tothe aperture via sealing ring 1189. A swivel 1187 may be connectedbetween the elbow 1188 and the air hose 1185. A swivel cuff (not shown)may be connected between the swivel 1187 and air hose 1185.

The mouth portion 1182 includes a lower lip engagement portion 1184adapted to form a seal below the patient's lower lip, an upper lipengagement portion 1186 adapted to form a seal just above the patient'supper lip, and a vanity flap to cover nares and/or nose tip—primarily tocover nose tip—or covering flap 1183 adapted to cover the patient'snares and the nares portion 1190, making the mask system 1180 morevisually appealing. The covering flap 1183 extends upward a sufficientheight to cover the patient's nares and the nares portion 1190.

The nares portion 1190 may include supporting portion 1192 and sealingportion 1193. The sealing portion includes nose tip engagement portion1194 and upper lip engagement portion 1196. The nares portion 1190 maybe connected to an upper aperture in the mouth portion 1182 via a mouthclip 1198 and a nares clip 1198.1, into which the nares portion 1190 maybe placed. When the nares portion 1190 is not to be used with the masksystem 1180, the nares portion 1190 is removed from the mouth clip 1198,and a plug may be put in the mouth clip 1198 or in the aperture toprovide a seal. The mouth clip 1198 may be silicone or another material,e.g., nylon, polypropylene, etc.

FIG. 47 illustrates a schematic cross-section view of the mask system1200 utilized in a nares and mouth mode, with mouth portion 1202 and anares portion 1220. The nares portion 1220 may be removable from themask system 1200 and replaceable with a plug, so that the mask system1200 may be used in a mouth only mode and the nares portion may be usedin a nares only mode.

The mouth portion 1202 includes a front portion 1204 or fascia, a lowerlip engagement portion 1206, an upper lip engagement portion 1208, anares portion tab 1210, vanity flap or covering flap 1212, and adecoupling portion 1214. The front portion or fascia 1204 may be a largeclear window allowing visibility of the patient's mouth region. Thenares portion tab 1210 may be adapted to receive and sealingly engagewith the nares portion 1220.

The nares portion 1220 includes an attachment ring 1229 adapted tosealingly engage with the mouth portion 1202, a supporting portion 1222,and a sealing portion 1224. The attachment ring 1229 may be co-molded,welded, permanently snapped or removably attached with the rest of thenares portion 1220. The sealing portion 1224 includes a nose tipengagement portion 1228 adapted to form a seal with the patient's nosetip, and an upper lip engagement portion 1226 adapted to form a sealjust above the patient's upper lip.

The covering flap 1212 is located in close proximity with the nose tipengagement portion 1228 of the nares portion 1220. Thus, if the coveringflap 1212 moves, the nose tip engagement portion 1228 may also move.Accordingly, the decoupling portion 1214 is included on the mouthportion 1202 at a position below the covering flap 1212. The decouplingportion 1214 serves to decouple forces applied to the mouth portion 1202(such as could be created by forces applied by movement of the air hose1232) from being transmitted to the nares portion 1220.

The mouth portion 1202 includes a lower aperture adapted to receiveelbow 1230, e.g., gusset elbow, which is connected to air delivery tube1232. The gusset elbow 1230 may include an anti-asphyxia valve and/orone or more vent holes for venting exhaled gases. The tube may connectto the nose cushion or pillows when in the nose-only mode.

FIGS. 48 and 49 illustrate a modular mask system 1260, which includes amouth portion 1262 and a nares portion 1280. The mask system 1260 isadapted to be used in a mouth only mode, a nares only mode or a mouthand nares mode.

The mouth portion 1262 includes a lower lip engagement portion 1264, anupper lip engagement portion 1266 adapted to push nasal seal intoengagement with the face, a decoupling (concertina) portion 1270 andaperture 1272. An aperture (not shown) on the front or bottom of themouth portion may be provided to connect a supply of air, such as airhose connected by an elbow or the like. The flexible portion 1270 couldbe air actuated or could be a thinner wall section, e.g., less stiff,and forms a decoupling portion that decouples forces applied to themouth portion 1262 from being applied to the nares portion 1280. Whenused in a mouth only mode, the aperture 1272 may be plugged to providean airtight seal.

The nares portion 1280 includes a supporting portion 1282, a sealingportion 1284 and headgear connectors 1290. The sealing portion 1284 isadapted to seal with the patient's upper lip and nose tip. When used ina nares only mode, the aperture 1274 can be connected to a source of airor plugged if air is alternatively supplied. When used in a nares andmouth mode, a nares clip 1286 may be connected, preferably permanentlyconnected or otherwise form into the supporting portion 1282, and amouth clip 1268 may be connected, preferably permanently connected orotherwise form into the cushion of the mouth portion 1262. The naresclip 1286 and the mouth clip 1268 are adapted to sealingly connect, suchas through notches or the like formed in the clips, so that the mouthportion 1262 may be connected to the nares portion 1280 in a nares andmouth mode.

FIG. 54 illustrates a cross section view of modular mask system 1350,which includes a mouth portion 1352 and a nares portion 1360. The naresportion 1360 may be removable from the mask system 1350 and replaceablewith a plug, so that the mask system 1350 may be used in a mouth onlymode, or the nares portion 1360 may be used in a nares only mode.

The mouth portion includes a frame 1354 and a mouth seal 1355. A firstaperture 1351 is positioned in the frame 1354 that is adapted to receiveelbow 1374 for delivery via swivel 1376 from an air hose. A secondaperture 1357 is formed in the frame 1354 that may be plugged when themask system is to be used in a mouth only mode, and connected to thenares portion 1360 when the mask system 1350 is used in a nares andmouth mode.

The frame 1354 may be a rigid material, e.g., polycarbonate or asemi-rigid material. The mouth seal 1355 may be a flexible material,e.g., silicone. The mouth seal 1355 includes a lower lip engagementportion 1356 adapted to form a seal below a patient's lower lip, and anupper lip engagement portion 1358 adapted to form a seal just above thepatient's upper lip (when used in a mouth only mode).

The nares portion 1360 includes supporting portion 1362 and sealingportion 1364. The sealing portion 1364 includes nose tip engagementportion 1368 adapted to form a seal with the patient's nose tip, andupper lip engagement portion 1370 adapted to form a seal just above thepatient's upper lip. The supporting portion 1362 may also form a sealjust above the patient's upper lip. A ring 1359 may be used to connectthe nares portion 1360 to the mouth portion 1352.

FIG. 60 illustrates a modular mask system 1430 that includes a mouthportion 1432 and a nares portion 1440. The mouth portion 1432 includes acushion portion 1434 adapted to form a seal around the patient's mouth.

The nares portion 1440 includes a supporting portion 1446 and a sealingportion 1442. The sealing portion is adapted to form a seal with thepatient's nares, and includes corners of the nose regions 1447 and upperlip engagement portion 1443.

Magnets 1436, 1448 may be placed on the mouth portion 1432 and the naresportion 1440 to ensure that the nares portion 1440 is oriented correctlyrelative to the mouth portion 1432. Either of the pairs of magnets 1436,1448 could be replaced by a metal portion. The magnets 1448 in the naresportion 1440 may be placed in the corners of the nose regions 1447 toensure sufficient tension of the nares seal over the patient's top lipand corners of the nose.

FIG. 61 illustrates a cross section view of modular mask system 1480,which includes a mouth portion 1482 and a nares portion 1490. The naresportion 1490 may be removable from the mask system 1480 and replaceablewith a plug, so that the mask system 1480 may be used in a mouth onlymode, or the nares portion 1490 may be used in a nares only mode.Alternatively, the system may be used in nares and mouth mode. In anexample, separate foam components may be provided for mouth and noseseal portions so that the mask system may be used in mouth only or naresonly modes.

The mouth portion 1482 includes a frame 1484 and a vanity flap orcovering flap 1486, a lower aperture 1485 for connection of swivel orcuff 1498 and air hose 1499, and an upper aperture 1487 for connectionof nares portion 1490. The frame 1484 may be a rigid material, e.g.,polycarbonate, or a semi-rigid material, e.g., semi-rigid nylon. A foamportion 1492 may have a clip 1493 for attaching to the frame 1484.

The nares portion 1490 may include a flexible portion 1496, a foamportion 1492 connectable to the flexible portion 1496 with one or moreclips 1493 and a nozzle portion 1494. The covering portion 1486 of themouth portion 1482 may support the nares portion 1490. Alternatively, apermanent connection may be used, e.g., foam portion directly ontoflexible portion.

FIGS. 61, 62 and 63 illustrate a modular mask system 1500, whichincludes a mouth portion 1502 and a nares portion 1510. The naresportion 1510 may be removable from the mask system 1500 and replaceablewith a plug, so that the mask system 1500 may be used in a mouth onlymode, or the nares portion 1510 may be used in a nares only mode.

The mouth portion 1502 includes a frame 1504 and a vanity flap orcovering flap 1509, a lower aperture 1505 for connection of elbow 1507,and an upper aperture 1503 for connection of nares portion 1510. Theframe 1504 may be a rigid material, e.g., polycarbonate, semi-rigid orflexible, e.g., nylon, silicone. A foam portion 1506 may have a clip1508 for attaching to the frame 1504.

The nares portion 1510 may include a flexible portion 1512, e.g.,silicone, and a foam portion 1516 connectable to the flexible portion1512 with one or more clips 1514. The covering portion 1509 of the mouthportion 1502 may be spaced from the nares portion 1510. The clips 1508,1514 may have a surface facing the foam portion that is angled to biasor promote the foam to apply force in certain directions, e.g., towardthe patient's lip.

FIG. 64 illustrates a modular mask system 1520, which includes a mouthportion 1522 and a nares portion 1540. The nares portion 1540 may beremovable from the mask system 1520 and replaceable with a plug, so thatthe mask system 1520 may be used in a mouth only mode, or the naresportion 1540 may be used in a nares only mode. Alternatively, the systemmay be used in a mouth and nose mode.

The mouth portion 1522 includes a frame 1523, a lower aperture 1527 forconnection of elbow 1560 (which may include vent holes 1562) and airhose 1566, and an upper aperture 1528 for connection of nares portion1540. The frame 1523 may be a rigid material, e.g., polycarbonate, or amore flexible material, e.g., silicone. A lower lip engagement portion1524 is adapted to form a seal with the patient's lower lip, and anupper lip engagement portion 1526 is adapted to form a seal with thepatient's upper lip.

The nares portion 1540 includes a supporting portion 1542 and a sealingportion 1544. The sealing portion 1544 includes an upper lip engagementportion 1548 adapted to seal just above the patient's upper lip and anose tip engagement portion 1546 adapted to form a seal with thepatient's nose tip or region proximate to the nose tip. In the upper lipregion, the supporting portion 1542 may be in contact with the upper lipengagement portion 1526 of the mouth portion 1522. When used in a naresonly mode, the aperture 1528 can be connected to a source of air orplugged if air is alternatively supplied.

When used in a nares and mouth mode, a connecting ring 1550 may beutilized. The connecting ring 1550 has a first channel 1552 and a secondchannel 1554. The first channel 1552 is adapted to receive the mouthportion 1522 and the second channel 1554 is adapted to receive the naresportion 1540.

FIG. 65 illustrates a modular mask system 1580, which includes a mouthportion 1582 and a nares portion 1590 that provide a soft to softconnection of nose and mouth parts. The nares portion 1590 may beremovable from the mask system 1580 and replaceable with a plug, so thatthe mask system 1580 may be used in a mouth only mode, or the naresportion 1590 may be used in a nares only mode.

The mouth portion 1582 includes a frame 1589, a lower aperture 1579 forconnection of elbow 1581, an air hose 1587, and an upper aperture 1577for connection of nares portion 1590. In an example, the elbow mayinclude buttons adapted to permit quick release of the elbow. Vent holes1585 may be formed in the elbow 1581, e.g., via a vented ring thatinterconnects the elbow and frame, or alternatively may be formed in themouth portion 1582. A lower lip engagement portion 1584 is adapted toform a seal with the patient's lower lip, and an upper lip engagementportion 1586 is adapted to form a seal with the patient's upper lip.

The nares portion 1590 includes a supporting portion 1592 and a sealingportion 1594. The sealing portion 1594 includes an upper lip engagementportion 1598 adapted to form a seal with the patient's upper lip and anose tip engagement portion 1596 adapted to form a seal with thepatient's nose tip.

The nares portion 1590 may have indentations 1595 adapted to form aninterference fit with the mouth portion 1582. The nares portion 1590 maybe resilient and be squeezed inward to accept the mouth portion in theindentations and then snap back into its original shape. The “trumpet”shape on the mouth portion provides a lead-in to guide the nares portioninto position. Also, a thin silicone wall may be provided to seal aroundthe nares portion.

FIG. 66 illustrates a modular mask system 1600 including a mouth portion1602, a nares portion 1610, elbow and swivel 1612, upper headgear 1618having a back strap 1619, and lower headgear 1620 having back loop 1622.

The upper headgear 1618 is adapted to connect to nares portion 1610 viaconnectors 1617, and the lower headgear 1620 is adapted to connect tomouth portion 1602 via connectors 1615. The back strap 1619 of upperheadgear 1618 may be inserted through back loop 1622 of lower headgear1620. Alternatively, another strap could be connected from back strap1619 to back loop 1622.

FIG. 67 illustrates a modular mask system 1630 including a mouth portion1632, a nares portion 1640, an elbow 1644 and an air hose 1646. Themouth portion 1632 may have an aperture 1634 adapted to receive a lugprovided on the back of elbow 1644. In this way, the nares portion 1644can operate independently of the mouth portion 1632, or can be connectedto the mouth portion 1632. In this example, the mouth portion may beconnected to the nares portion without disconnecting the elbow.

Example Cushion 1

FIGS. 68-73 illustrate mask system 1650, having a mouth portion 1652 anda nares portion 1660. FIG. 74 illustrates the nares portion 1660 andFIG. 75 illustrates the mouth portion, fascia or support structure 1652.FIGS. 76 through 89 illustrate the cushion 1654 of the mouth portion1652.

The mouth portion 1652 is removably detachable from the nares portion1660, although both portions may be co-molded. Sealing ring 1665 (FIG.73 ) may be used to connect the mouth portion 1652 to the nares portion1660. An aperture 1656 is adapted to connect to a supply of air todeliver air to the mask system 1650. The mouth portion includes cushionfascia portion 1657 (which may be transparent or semi-opaque),decoupling portion 1659, which may be a thinned portion compared to theremainder of the front of the mouth portion, to decouple forces appliedby movement of the elbow/air hose connected to aperture 1656 from therest of the mask system 1650.

Vanity flap or covering flap 1658 covers/supports the patient's naresregion. Preferably, vanity flap covers all or portion of the nares sealportion 1660. Such an arrangement may be less visually obtrusive to thepatient and may aid in stabilizing the nares seal portion 1660.

Cushion 1654 connects to the cushion fascia portion 1657 and is adaptedto form a seal around a mouth of a patient. The connection of thecushion 1654 to the cushion fascia portion 1658 may be by aninterference fit e.g. tongue and groove.

Lower headgear connectors (not shown) may be placed on the front of themouth portion 1652 in a manner such as illustrated in FIG. 24 . Thecushion 1654 and the cushion fascia portion 1657 may both have ahardness of 40 Shore A, or similar. Alternatively, the cushion fasciaportion 1657 may have a relatively higher hardness compared to cushion1654. Cushion fascia portion 1657 may be constructed of a semi-rigidpolymer such as nylon, polycarbonate, polypropylene. Cushion fasciaportion 1657 may have a hardness of 40-80 Shore A. Cushion 1654 may beconstructed of a conformable material for example silicone, foam, gel,TPE. Cushion 1654 may be constructed of a material having a hardness of5-40 Shore A, for example 5-25 Shore A.

Cushion 1654 may be constructed of a combination of materials, forexample a first portion proximate the cushion fascia portion having afirst hardness and a second portion proximate a patient contactingportion having a second hardness. Preferably the first hardness isgreater than the second hardness, to provide structural support to thepatient contacting portion. For example, the first portion may have ahardness of 25-60 Shore A, 35-50 Shore A. The second portion may have ahardness of 5-25 Shore A, 5-15 Shore A. The first portion may be thickerthan the second portion, for example the first portion may be 1-3 mm,1-2 mm, and the second portion may be 0.1-2 mm, 0.1-1 mm or about 0.8mm. The combination of a thin wall section and soft material at thesecond portion may permit the cushion to be more compliant and flexible,thereby shaping to the patient's face. The thicker first portionprovides structure to provide stabilization. Together, they allow asingle wall cushion that substantially emulates a dual wall cushion.

Preferably, cushion 1654 may be flexible and/or may have a lowerhardness (e.g. 5-15 Shore A) in the chin region 1693 so that when thecushion is placed on the user's face, the cushion stretches over thepatient's chin. The stretching of the cushion in the chin region 1693may cause the cushion to be in tension over the patient's chin, whichmay form a robust seal with the patient's chin as well as ensuring thatthe cushion may fit a wider range of chin geometries.

The cushion 1654 includes a cushion fascia connecting portion 1655 (FIG.76 ) adapted to connect to the cushion fascia 1657, a ring connectingportion 1680, and a pocket 1684. In an alternative, the cushion fasciaand cushion may be formed in one piece. The ring connecting portion 1680includes an aperture 1682 adapted to receive connecting ring (to connectthe mouth portion 1652 to the nares portion 1660). In an alternative,the ring connecting portion and connecting ring may be formed in onepiece. In a further alternative, the cushion may be formed with a firstconnecting ring and the nares portion may be formed with a secondconnecting ring, first connecting ring being received by the secondconnecting ring (or vice versa).

The pocket 1684 is adapted and shaped to receive the gusset 1671 (FIG.74 ) of the nares portion 1660, or other portion of nares portion 1660for example the headgear connector portion of nares portion 1660. Adifferent shaped pocket may be used if a different nares portion isused. The pocket 1684 is sunken in the cushion 1654 so as not to disturbthe seal of the cushion 1654 when the nares portion 1660 is in thepocket 1684. That is, pocket 1684 may be disposed or offset under orbelow the uppermost surface of the mouth cushion 1654.

Pocket 1684 may also be a sunken portion, groove, trench, hollow, pouch,alcove, indentation, dip, pit, valley or sinkage—i.e. a region of thecushion that is adapted to receive a nares portion, the region having analternate or abstract geometry when compared to the rest of the mouthcushion. The pocket may not be a hole, cut out or aperture. Preferablythe pocket is air tight. Preferably the pocket is formed by a soft,conformable material such as the mouth cushion, rather than the frame.Such an arrangement is preferable as a conformable pocket may permitadjustment of the position of the nares portion, thereby fitting morepatients. Preferably, the pocket permits movement of the nares portionin the superior-inferior direction, to accommodate varying patient noseheights. Preferably the pocket may increase in stiffness when airpressure is applied in the mouth cushion for example. Preferably thepocket may stabilize the nare portion in position in the medial-lateraldirection. This may be achieved by the shape of the pocket, adapted tomatch the shape of the nares portion. such an arrangement may ensurethat the nares portion maintains sealing engagement with the patient'snares in use when tube drag or other forces are applied to the side ofthe mask.

The nasal seal portion may reside or rest in the pocket. The patientcontacting portion of the nasal seal portion may be positioned outside,above or higher than the pocket. Such an arrangement may ensure that thepatient can see the nasal seal portion contacting their nose to ensurealignment and seal.

In one form the nasal seal portion may not be in air flow communicationwith the mouth portion via the pocket.

The pocket may have a lower stiffness than surrounding portions of themouth cushion. The pocket may have a comparably thinner wall sectionthan other regions of the mouth cushion. The pocket may be formed from adifferent material to the rest of the mouth cushion.

Preferably the pocket is continuous with or formed in one piece with thetop lip contacting region of the mouth cushion and is thus in sealingengagement with the patient's top lip.

The mouth cushion may comprise a top lip region adapted to interfacewith the patient's top lip. The mouth cushion may further comprise acheek region adapted to interface with the patient's cheek and/or sideof mouth. The mouth cushion defines a wall, the wall located between apatient contacting portion of the mouth cushion and a frame contactingportion of the mouth cushion. The wall may comprise different portions,for example a top lip wall portion, a chin wall portion and two cheekwall portions, each corresponding to the respective top lip, chin andcheek regions of the patient's face. In one form, the cheek wall portionmay be comparably stiffer than the top lip wall portion. In anotherform, the chin wall portion may be comparably stiffer than the top lipwall portion. Preferably the top lip portion may be less stiff than thecheek wall portions. In such an arrangement the cheek contacting portionmay act in compression on the patient's cheeks, such that the top lipand chin regions may be in tension.

Pocket 1684 in the present example may comprise a curved groove havinglobes or regions 1661 as shown on FIG. 78 . Lobes 1661 may be shaped tocorrespond to gusset 1671 as shown on FIG. 74 . The lobes may beseparated by a ridge or indentation 1663 adapted to indicate thealignment or positioning of the nasal portion 1660.

Pocket 1684 may have a maximum width w1 of approximately 30-60 mm.Preferably, pocket 1684 may have a maximum width w1 of approximately35-45 mm. Preferably, pocket 1684 may have a maximum width w1 ofapproximately 40-45 mm.

Pocket 1684 may have a length d5, as shown on FIG. 85 , of about 15-40mm. Preferably, pocket 1684 may have a length d5 of about 20-30 mm. Thislength may be the approximate length from the fascia contacting side ofthe pocket to the outer most edge of lobe 1661.

Lobes 1661 of pocket 1684 may be offset or angled with respect of oneanother to position the nasal seal to be positioned at the angularregion of the maxilla (patient's top lip). Lobes 1661 of pocket 1684 maybe angled with respect of one another by angle α1 of approximately90-180°. Lobes 1661 of pocket 1684 may be angled with respect of oneanother by angle α1 of approximately 90-150°. Lobes 1661 of pocket 1684may be angled with respect of one another by angle α1 of approximately90-180°. Lobes 1661 of pocket 1684 may be angled with respect of oneanother by angle α1 of approximately 90-150°.

The chin or lower seal region 1693 of mouth cushion 1654 may be roundedor curved to conform to a patient's chin. Radius of curvature r1 maypreferably be 20-50 mm. Radius of curvature r1 may preferably be 30-40mm. Radius of curvature r1 may preferably be 35-45 mm.

The nares portion may be secured to the cushion 1654 by connection tothe connecting ring. The cushion may also have a thickened portion 1686(FIGS. 80 and 81 ) to support connection to cushion fascia portion 1657.Also, the thickened portion 1686 supports the sealing portion inposition and prevents collapse of the sealing portion, particularly ifthe sealing portion is constructed of a low hardness, low thicknessmaterial, i.e., it will lack structural rigidity.

The nares portion 1660 includes a sealing portion 1662 adapted to form aseal with the nares of the patient, and headgear connectors 1670 forconnecting to headgear. The sealing portion 1662 may be in the form ofnozzles, although other sealing portions may be used, such as pillows,prongs, etc. Exemplary sealing portions are disclosed in WO 2009/052560A1, which is incorporated herein by reference in its entirety.

The cross sections illustrated in FIGS. 82-84 are shaped to accommodateflat faces and more pointy faces of patients due to the question marklike shape of the cross section. FIG. 83 shows the cross section at thehorizontal plane that may be positioned generally on the cheeks or thelateral extents of the patient's mouth. In this region, the crosssection of the cushion shows that the membrane is comparably longer thanat the bony upper or lower jaw regions (shown in FIGS. 82 and 84 ). Thismay be to reduce the force of the cushion on the patient's cheekscompared to the bony upper or lower jaw regions, as the longer membranemay absorb more force than the shorter membrane. This may be because thepatient's cheeks are more sensitive than the bony regions of the face.The shape of the cushion is shaped to match a shape of a face, asillustrated in FIG. 79 , e.g., a C-shape. As illustrated, the sealingmembrane includes a varying thickness along its length, e.g., from thickto thin. This varying thickness may be so that a patient contactingportion is supported and positioned by the thicker region, and thepatient contacting region may be comfortable and conformable due to thethinner region. The patient contacting portion may be approximately0.2-2 mm. Preferably, patient contacting portion may be approximately0.8-1.2 mm. Thicker region 1686 may be approximately 0.5-4 mm.Preferably thicker region 1686 may be approximately 2-3 mm.

In a further example, the load imparted by the cushion on the user'sface at the top lip region 1692 may be greater than the load imparted bythe cushion on the user's face at the chin region 1693. This may beachieved by having a comparably greater thickness at the top lip region1692 compared to the thickness at the chin region 1693. Such anarrangement may assist in anchoring the cushion on the patient's face,while ensuring that the force on the lower jaw is low. High forces onthe lower jaw may force the upper airway to collapse and therebyexacerbate obstructive sleep apnea, so it is desirable to have a lowerforce on the patient's lower jaw and hence chin region 1693.

The pocket 1684 is structured to accommodate the nares portion, and airinside the nares portion ensures a seal across the top lip. The nestingnares portion and cushion make the mask less obtrusive. Pocket 1684 mayhave a depth d1 of approximately 5-30 mm. Preferably, pocket 1684 mayhave a depth d1 of approximately 5-20 mm. Preferably, pocket 1684 mayhave a depth d1 of approximately 5-10 mm. The depth of pocket d1 can beseen in FIGS. 80-81 .

As best shown on FIG. 80 , pocket 1684 may be adjacent or connect to aflap seal portion at the top lip region 1692. A ridge or apex 1694 maybe formed between the pocket 1684 and the top lip region 1692. Ridge1694 may act to divide the pocket from the top lip region, and may alsoprovide a hinge or spring point for the top lip region.

As best shown at FIGS. 80 to 81 , pocket 1684 may be generally curved orrounded in a cup like shape as indicated at c1.

At chin region 1693, as best shown on FIG. 80 , the cushion may have adepth d2 i.e. the distance from the sealing region or patient contactingportion of the chin region to the connecting region 1655, ofapproximately 0.5-3 mm. Depth d2 may be approximately 1-2 mm, Preferablydepth d2 may be approximately 1.5-2 mm. This depth may be desired so asto ensure different shaped chins may be accommodated by the mouthcushion 1654. Chin lip region 1693 as shown in FIG. 85 demonstratesdepth d4. Depth d4 may be substantially similar to depth d1.

Cushion 1654 may have a cheek region 1695, and at the cheek region 1695the cushion may have a depth d2, shown on FIGS. 82 . 83 and 84. Depth d2may be larger than d1, d4. Such an arrangement may be preferable so thatcushion 1654 may flex and deform at the cheeks to a greater extent thanat the top lip, so as to anchor the cushion on the top lip and permitvariations in the facial geometry of patients. For example, somepatients may have relatively flat faces while others may have relativelypointy faces, so the cushion should be able to conform to each of thesefacial profiles. For example, depth d2 may be approximately 10-50 mm.Preferably, depth d2 may be approximately 20-35 mm. Preferably, depth d2may be approximately 20-30 mm.

The curvature of the top lip region 1692 of the cushion ensures tensionacross the patient's top lip and therefore seal. The spring shapecross-section at the top lip lowers force displacement at the patient'stop lip (sensitive region).

FIG. 86 shows the mouth cushion 1654 as viewed from the patientcontacting side. The top lip region 1692 has a height d6, which may beless than height d7 of chin region 1693. This may be because typically aperson's face has a smaller distance between the top lip and bottom ofthe nose when compared to the distance between bottom lip and the tip ofthe chin. For example, height d6 may be 5-15 mm. Preferably, height d6may be approximately 8-10 mm. Height d7 may be approximately 10-25 mm.Preferably, height d7 may be approximately 12-16 mm.

Example Cushion 2

FIGS. 92A-E and 93A-I illustrate a variant of a mouth cushion 2100 whichis similar to that shown in FIGS. 76-89 , and share common features suchas a pocket adapted to receive a nasal seal portion and a single sidewall 2104 that is thicker at its base where it connects to the fasciaand thinner at its distal end where it seals with the patient. The sidewall has a sickle or question mark type shape.

Mouth cushion 2100 may have a top lip region 2692, chin region 2693 andcheek regions 2695. Mouth cushion may further include connecting region2655 for interfacing the mouth cushion with a clip, frame or otherportion of the mask assembly.

The top lip region 2692 and chin region 2693 of the seal portion areformed generally flat such that the seal is stretched (by tension) onthe patient's face to enhance the seal. This is beneficial since theheadgear, even if tightened, would not be able to significantly changethe sealing forces in this area.

The pocket 2102 is thinner compared to the pocket 1684 in FIG. 76 . Thisallows the nasal seal to more directly add some component of sealingforce—i.e. as the nasal seal is pressurized the nasal seal may becomestiffer and thereby impart force on the top lip seal portion. Thereduction in thickness may also reduce weight and/or material.

In addition, cushion 2100 does not have a ring connecting portion 1680as in FIGS. 86-89 (for example). Thus, air flow to the nasal sealportion is not transmitted through the mouth cushion. Instead, a clipmay be provided that is adapted to receive both the mouth cushion andthe nasal cushion, and may provide the pathway to transmit air to thenasal cushion.

Pocket 2102 may not be a cup like shape, rather it may have an open backand curve upwards (see c2 shown on FIGS. 93D and 93E) to ridge 2694 tothen adjoin top lip portion 2692.

Pocket 2102 may have a similar depth to pocket 1684, as indicated atdepth e1 on FIGS. 93D and 93E. Depth e3 may also be similar to depth d3,depth e4 may be similar to depth e4 and length e5 may be similar tolength e5.

Depth e2 as indicated on FIG. 93D shows the distance from the edge orconnecting region to the patient contacting portion. Depth e2 may beabout 10-30 mm, preferably 15-25 mm. Radius of curvature r2 may belarger than the radius of curvature r1 from Example 1. Such a depth andradius of curvature r2 may be to ensure that the depth at the chinregion 2693 is similar to that at cheek region 2695. This may flattenout the cushion in the chin region, so that when the patient positionstheir chin against chin region 2693, the membrane stretches over theirchin. This may ensure a more stable seal and a larger fit range.

Width w2 as shown on FIG. 93A may be larger than width w1. This may beto accommodate a longer nasal seal portion or to move the same nasalseal portion from Example 1 further down into mouth seal portion 2100(i.e. position the nasal seal further from the top surface or deeper inthe mouth cushion 2100). Width w2 may be about 50-70 mm. Preferably,width w2 may be about 50-60 mm.

Example Cushion 3

Referring to FIGS. 104-131 , a mask system 400 according to anembodiment of the present technology comprises a mouth cushion 4100, acushion clip 4200 and a fascia 4300. The mouth cushion 4100 shares somecommon features with Example Cushion 2, such as a pocket 4102 adapted toreceive a nasal seal portion, and a sealing portion 4106 configured toform a seal with the patient's face. Other common features may beevident from the following description of the mask system 4000. Themouth cushion 4100 may be formed of, for example, silicone. The cushionclip 4200 may be formed of, for example, thermoplastic. The fascia 4300may be formed of, for example, thermoplastic.

The mouth cushion 4100 may be over-moulded to the cushion clip 4200. Itshould be appreciated that the mouth cushion 4100 may be detachablyconnected to the cushion clip 4200 in a manner described below. Themouth cushion 4100 comprises the pocket 4102, an upper connectingportion 4104 adapted to receive a nasal seal connecting portion 4202 ofthe cushion clip 4200 and retain the mouth cushion 4100 to the fascia4300. Referring to, for example, FIG. 117 , the upper connecting portion4104 is tilted or offset away from the sealing portion 4106 so as toallow the nasal seal portion (not shown) to orient toward the patient'snasolabial angle. Referring to, for example, FIGS. 104, 112 and 113 , arear edge 4108 of the pocket 4102 and the upper connecting portion 4104form an aperture 4110 that receives the nasal seal connecting portion4202 of the cushion clip 4200. The nasal seal connecting portion 4202 ofthe cushion clip 4200 fits within the aperture 4110 of the upperconnecting portion 4104 and the rear edge 4108 of the pocket 4102.

Referring to, for example, FIGS. 120-124 , the mouth cushion 4100includes a groove 4114 that is configured to receive the cushion clip4200. The groove 4114 almost completely encloses the cushion clip 4200.A small gap is provided in the groove 4114 to allow tabs 4218 (FIGS.139-145 ) of the cushion clip 4200 to extend outwards and engage withand interlock with slots 4310 (FIGS. 134, 135 and 138 ) of the fascia4300. The mouth cushion 4100 further comprises a lip seal 4112 tointerface with a groove 4302 (FIGS. 104, 109-111 and 138 ) of the fascia4300 formed by a tab 4304. As shown, for example, in FIGS. 110 and 111 ,the lip seal 4112 is shown as overlapping with the tab 4304 of thegroove 4302 of the fascia 4300. However it should be appreciated that inthe assembled state, the relatively flexible lip seal 4112 will deformand bend into the groove 4302 and be retained by the tab 4304 of thefascia 4300.

Referring to FIGS. 125-131 , the cushion clip 4200 comprises a fitting4204 to receive a ring of the nasal seal portion (not shown). Thefitting 4204 includes reliefs 4206 to permit flexing of the fitting 4204and tabs 4208 to retain the ring of the nasal seal portion. The cushionclip 4200 further comprises supporting regions or portions 4210 on lowercorners of the clip 4200 to increase stability and force on the cushion4100 in the patient's cheek regions to provide a more stable seal on thesoft areas of the patient's face. Supporting regions 4210 on lowercorners of the clip 4200 may be thicker or stiffer than adjacentportions of the cushion clip 4200. A fascia contacting lip 4212 isprovided to engage the groove 4302 of the fascia 4300. A cushioncontacting lip 4214 is provided to engage the groove 4114 of the mouthcushion 4100.

Referring to FIGS. 132-145 , the fascia 4300 comprises lower headgearconnectors 4306 for connecting to the headgear and an elbow connector4308 for connecting to an elbow adapted to be connected to a gasdelivery tube or conduit. The rear surface of the fascia 4300 includesthe groove 4302 (FIG. 138 ) adapted to engage flexible lip seal 4112 ofthe mouth cushion 4100. The rear surface also includes slots 4310 thatare configured to receive and interlock with tabs 4218 of the cushionclip 4200. As shown in FIGS. 138 and 145 , the tabs 4218 are rounded tosmoothly guide the tabs 4218 into the slots 4310 of the fascia 4300.Tabs 4218 may also be rounded so that the upper tab adjacent fitting4204 may be connected first and in a first position, then the cushionclip can be rotated to position upper tab in a second position, thissecond position permitting lower labs adjacent lower headgear connectors4310 (in use) to engage with fascia 4300.

1.8 Cushion-to-Fascia Interface

FIGS. 94-102 illustrate an example of a cushion to fascia interface.FIGS. 94 and 95 illustrate the mask assembly in its assembled condition,including pillows 3000, mouth cushion subassembly 3002 and elbow 3004.FIG. 96 illustrates an exploded view thereof.

FIG. 97 is an exploded view of subassembly 3002, including cushion 3006and fascia 3008. Cushion 3006 includes a clip 3010 that may beovermolded on to the cushion. Cushion 3006 may be removably connected toclip 3100.

Clip 3010 may have a fitting 3012 for attachment to the pillows 3000.Fitting 3012 may comprise reliefs 3013 to permit fitting 3012 to flexinwards and thereby accept a nasal seal portion. Fitting 3012 may alsocomprise tabs 3014 adapted to lock or maintain the position of the nasalseal portion once it is connected. Fitting 3012 may be angled in such away so as to present the nasal seal portion directly towards thepatient's nares. For example, FIGS. 94 and 95 shows the nasal sealportion 3000 oriented to approximate the patient's nasolabial angle.

Clip may be more rigid than cushion, and may be made of Hytrel,polypropylene, nylon, injection molded plastic, etc.

FIG. 98A shows the patient side of the fascia 3008. Fascia 3008 mayinclude recess 3008.1 at the top of the fascia and recesses 3008.2 atthe lower side corners of the fascia. Fascia 3008 may further includelugs or ridges 3008.3 adapted to align and/or position the mouth sealportion and/or clip. The outer side or non-patient contacting side offascia 3008 may be curved or stepped such that the middle portion israised compared to the side portions. This may aid a patient in pickingup the fascia as they can grip on to the curved regions. These curvedregions may further include gripping portions (not shown) such asdimples or overmolded buttons to aid the patient in gripping the fascia.

FIG. 97 is a further exploded view showing that the fascia 3008 and setclip 3010 may be clipped together at a number of locations, e.g., two ormore, and in this case three locations. As shown in FIGS. 98A, 98B and99 , fascia 3008 may have a recess 3008.1 to receive a projection 3010.1of clip 3010. FIGS. 100-102 show a sequence of an exemplary fittingassembly between the subassembly 3002. FIG. 100 shows initial engagementbetween the projection 3010.1 and recess 3008.1 at the top of the mask,after which the mask is pivoted in FIG. 101 . Once the lower end of clipreadies to the lower part of fascia 3008, the clip snaps home forcomplete assembly.

The clip may include an integrated (silicone) lip seal to prevent leakbetween the clip and the fascia 3008. This would make the assembly morerobust and less dependent on tolerances to prevent leak. The lip sealmay be located in close proximity to the projections 3010.1 or 3010.2.FIG. 103 shows an example of a lip seal 3011 that may be used in suchassembly.

1.9 Integrated Mask System

FIGS. 14 and 15 illustrate another mask system 101, which is anintegrated mask system. The mask system 101 includes a nares portion120, a mouth portion 140 and a flexible tube 105 connected to the mouthportion 140 via an elbow 102.

The nares portion 120 may utilize a nares sealing portion 122, which maybe in the form of nasal pillows, prongs, a membrane seal such as a nasalcradle, and/or a nasal chamber. The nares sealing portion 122 may be inthe form of the nares sealing portion 222 illustrated in FIGS. 19 and 20. The nares portion 120 may further include decoupling portion 125 andheadgear connectors 121 adapted to connect to headgear 160.

The mouth portion 140 may include a structural portion 147, a mouthsealing portion 142, decoupling portion 145, headgear connectors 141,and vent 103, which may include one or more vent holes or slots forventing gas exhaled by the patient. A nares portion connector 143adapted to connect to the nares portion 120 may be utilized when thenares portion 120 and the mouth portion 140 are not formed as a unitaryelement. The mask system 101 could alternatively be formed as a modularmask system, where the nares portion 120 and the mouth portion 140 areseparable and may be used individually, and the nares portion 120 isconnectable to the flexible tube 105 via elbow 102.

FIGS. 16-18 illustrate another mask system 201, which includes a naresportion 220 and a mouth portion 240. The nares portion 220 may include anares sealing portion 222, an orifice 226 for receiving pressurized,breathable gas. The mask system 201 is illustrated with a nares sealingportion 222 such as illustrated in FIGS. 19 and 20 , although othernares sealing portions could be utilized, such as pillows, prongs, anasal chamber, etc.

The mouth portion 240 includes a mouth seal portion 242 which may be inthe form of a cushion for sealing with the mouth of the patient, a frame247, a mouth orifice 246 for receiving the pressurized, breathable air,a decoupling portion 245, and a nares connecting portion 243 forconnecting with the nares portion. FIG. 16 is illustrated with the frame247, the decoupling portion 245 and the connecting portion 243 removed.Although not illustrated, the mouth portion 240 may include connectionto a flexible tube for delivery of the pressurized, breathable gas, suchas the swivel connector, elbow and flexible tube illustrated in otherembodiments.

The mask system 201 could alternatively be formed as a modular masksystem, where the nares portion 220 and the mouth portion 240 areseparable and may be used individually, and the nares portion 220 isconnectable to the flexible tube 105 via elbow 202.

FIG. 23 illustrates a mask system 370, which may include a nares portion372, a mouth portion 380, and headgear 360. In this embodiment, the masksystem 370 may have the nares portion 372 and the mouth portion 380integrated. The lower headgear strap 379 passes under the patient's earsand provides a normal headgear vector force or sealing force on thepatient's face. The headgear strap 360 provides a supporting force toaide positioning and stabilization of the mouth portion 380 on thepatient's face. The headgear strap 360 does not connect near the mouthof the patient to aid in keeping obtrusiveness of the mask to a minimum.

The nares portion 372 may include nares sealing portion 374 and mouthsealing portion 375. Decoupling portions may be included.

FIG. 27 illustrates a schematic cross-section view of an integrated masksystem 201 where the nares portion 220 and the mouth portion 240 areformed as a unitary element. The decoupling portion 245 is formed in themouth portion 240, and may decouple forces applied to the mask system(such as from a flexible supply tube) from the mouth portion 240. Thenares sealing portion 222 is a nares sealing portion such as illustratedin FIGS. 19 and 20 . The nose tip engagement portion 254 seals with thepatients nose tip and the upper lip engagement portion seals with thepatient's upper lip. This schematic cross-sectional view omits theconnection to the flexible tube.

FIG. 28 illustrates a schematic cross-sectional view of an integratedmask system 101, where the nares portion 120 and the mouth portion 140are formed as a unitary element. This schematic cross-sectional viewomits the connection to the flexible tube 105. In this embodiment, themouth sealing portion 142 extends from the mouth portion 140 where themouth sealing portion 142 seals with the area between the patient'slower lip and the patient's chin, and extends from the nares portion 120where the mouth sealing portion 142 seals with the patient's upper liparea. A decoupling portion may be formed in the mouth portion 140, andmay decouple forces applied to the mask system (such as from a flexiblesupply tube) from the mouth portion 140.

FIG. 31 illustrates a schematic cross-sectional view of an integratedmask system 370, where the nares portion 372 and the mouth portion 380are formed as a unitary element. The nares portion 372 includes a naressealing portion 374 that forms a seal with the patient's nares, and amouth sealing portion 375 that forms a seal with the patient's mouth. Agusset 376 may be provided to connect the mouth portion 380 to flexibletube 305. The gusset 376 may function to decouple movement of flexibletube 305 from disrupting the seal of the mouth portion 380 and/or thenares portion 372.

FIGS. 50-52 illustrate an integrated mask system 1300. The mask system1300 includes mouth portion 1302 and nares portion 1310. The mouth sealof the mouth portion 1302 is oriented generally horizontally, while thenares portion 1310 is oriented generally vertically to anatomicallymatch the mouth and nares of the patient. A gas washout vent may also beincluded.

The mouth portion 1302 includes a lower lip engagement portion 1304 thatis adapted to form a seal with a patient's lower lip, an upper lipengagement portion 1306 adapted to form a seal with the patient's upperlip, and an aperture adapted to receive pressurized air from air supplyhose 1318. An elbow and/or swivel may be used in conjunction with theair supply hose 1318.

The nares portion 1310 includes a nares engagement portion 1314 adaptedto form a seal with the patient's upper lip, a nose tip engagementportion 1312 adapted to form a seal with the patient's nose tip, and aconcertina or decoupling portion 1316 (e.g., see FIG. 50 ). Theconcertina portion 1316 decouples forces applied to the mouth portion1302 from being applied to the nares portion 1310. The concertinaportion may also fill with air, and utilize air pressure to increase theforce and thereby provide a more robust seal.

FIG. 53 illustrates an integrated mask system 1320. The mask system 1320includes a mouth portion 1322 and a nares portion 1330.

The mouth portion 1322 includes a lower lip engagement portion 1324adapted to form a seal with the patient's lower lip, and a frame 1326.The frame 1326 may be a rigid material, e.g., polycarbonate. The lowerlip engagement portion 1324 may be co-molded with the frame 1326.

The nares portion 1330 may include a supporting portion 1332, a sealingportion 1334 and a clip portion 1338 adapted to engage the sealingportion 1334 with the supporting portion 1332. The supporting portion1332 may be a semi-rigid material, e.g., nylon. The clip portion 1338may be a semi-rigid material, e.g., nylon or polypropylene.

The sealing portion 1334 includes an upper lip engagement portion 1337adapted to form a seal with the patient's upper lip, and a nose tipengagement portion 1336 adapted to form a seal with the patient's nosetip. The sealing portion 1334 may be a flexible material, e.g.,silicone. The sealing portion 1334 may be co-molded as one piece withthe frame 1326.

An air supply hose 1344 may be connected to the mouth portion 1322 by aswivel 1342. The swivel 1342 may be a rigid material, e.g.,polycarbonate.

FIG. 57 illustrates a modular mask system 1400 and FIGS. 58 and 59illustrate a related integrated mask system (which could be modular).The mask system 1400 includes mouth portion 1402 and nares portion 1410.An elbow 1407 connects an air supply hose 1409 to the mouth portion 1402to deliver air to the mask system 1400. Headgear 1420 connects to themask system 1400 to secure the mask system 1400 to the patient's head.

The mouth portion 1402 includes a front portion 1404 and a lower foamportion 1405. The lower foam portion 1405 is positioned to form a sealbetween the patient's lower lip/chin and the mouth portion 1402. Thefront portion 1404 may be a clear portion allowing visibility of thepatient's mouth region. The front portion 1404 may be silicone, forexample.

The nares portion 1410 may include a supporting portion 1412 and asealing portion 1414. The sealing portion 1414 may include a nose tipengagement portion 1416 adapted to form a seal with the patient's nosetip, and an upper lip engagement portion 1418 adapted to form a sealwith the patient's upper lip. The supporting portion 1412 may also forma seal with the patient's upper lip. An upper foam portion 1406 may bedisposed between the nares portion 1410 and the patient's upper lip toprovide additional comfort. An outer foam portion 1408 may be disposedbetween the front portion 1404 and the nares portion 1410. The upperfoam portion 1406 and the outer foam portion 1408 may be one foam piece,such as a ring shaped piece of foam, with a hole formed in the foam forinsertion of the nares portion 1410.

1.10 Kits

Various components of the disclosed mask systems may be utilized in oneor more kits that may be provided. For example, FIG. 33 illustrates anares only kit 805 that may be provided according to embodiments of thepresent technology. The nares only kit 805 may include a nares portion820 adapted to seal with and provide respiratory therapy to a patient'snares, and nares portion headgear 812. The nares only kit may optionallyinclude an elbow or other connector 802 that may connect the naresportion 820 to a supply of pressurized air, although such an elbow orother connector 802 may be provided as part of the nares portion 820.The nares portion 820 may include plug 35 in the embodiment of FIGS. 1-1to 4 . However the nares only kit 805 may be provided with acommercially available mask, e.g., the Swift FX mask. Plug 35 may beremoved if utilized with the mouth portion 840.

The nares only kit 805 is adapted to provide a patient with respiratorytherapy to a patient's nares. This form of respiratory therapy, providedto the nares only, is preferred because it is less obtrusive to wear,and more comfortable for a patient, and many patients only need narestherapy. However, some patients may need mouth therapy, either mouthonly therapy or mouth and nares therapy. For example, some patients whomay be mouth breathers need a mouth portion to provide a mouth seal sothat effective therapy may be applied to the nares. Other patients mayneed mouth only therapy or mouth and nares therapy.

Accordingly, mouth kit 810 may be provided to a patient that needs mouthonly therapy, or needs mouth and nares therapy but already has a naresonly device or nares only kit 805. The mouth kit 810 may include a mouthportion 840 that is adapted to seal with and provide respiratory therapyto a patient's mouth, and mouth portion headgear 850. The mouth portion840 may be adapted to provide respiratory therapy only to a patient'smouth. The mouth kit 810 may optionally include an elbow or otherconnector 802 that may connect the mouth portion 840 to a supply ofpressurized air, if such a connector is not incorporated in the mouthportion 840.

The mouth portion 840 may optionally be adapted to connect pneumaticallyto nares portion 820 or another nares only CPAP device. For example, themouth portion 840 may include the aperture 46 illustrated in FIG. 1-5adapted to connect to a nares portion, in which case plug 35 may also beprovided in the mouth kit 810 for plugging aperture 46. The mouthportion 840 may also optionally include the valve 55 for selectivelyclosing the aperture 46. Further, the mouth kit 810 may be optionallyprovided with plug 803, which may be used to plug an aperture in thefront of the mouth portion 840, and may optionally be provided withdouble elbow 855, that may be used to connect both the mouth portion 840and the nares portion 820 to a supply of pressurized air. The mouthportion 840 may function as a docking station, where the mouth portion840 is adapted to dock with the nares portion 820.

The mouth kit 810 may also be optionally provided with nares and mouthportion headgear 860, which includes a connection region in the backportion, such as connection region 67 illustrated in FIG. 7 . The naresand mouth portion headgear 860 may be used instead of the nares portionheadgear 812 and the mouth portion headgear 850. Further, the mouth kit810 may also be optionally provided with connected nares and mouthportion headgear 870, which includes a connector 856 for connecting thenares only headgear and the mouth only headgear at a back portion.

The nares only kit 805 may be utilized as a retrofit kit to a patienthaving a mouth portion kit 810 or other mouth portion, who wants toconvert his mouth only device into a mouth and nares device. In thiscase, the nares only kit may optionally be provided with the doubleelbow connector 855, with the plug 803, with the nares and mouth portionheadgear 860, or with the connected nares and mouth portion headgear870. Likewise, the mouth kit 810 may be provided as a retrofit kit to apatient having a nares only kit 805 or other nares portion, who wants toconvert his nares only device into a nares and mouth device.

The patient may utilize the nares only kit 805 and/or the mouth kit 810to convert the nares only CPAP device 805 into a nares and mouth CPAPdevice in several ways. The patient may remove the elbow or otherconnector from the nares portion 820, and connect the double elbowconnector 855 to both the nares portion 820 and to the mouth portion840, so that air is delivered through the double elbow connector 855 toboth the nares portion 820 and the mouth portion 840. The patient mayutilize the original nares portion headgear 812 on the nares portionalong with mouth portion headgear 850 on the mouth portion 840. Theconnector 856 may optionally be utilized to connect the nares portionheadgear 812 to the mouth portion headgear 850. Alternatively, nares andmouth portion headgear 860 could be provided to connect to the naresportion 820 to the mouth portion 840. The nares and mouth portionheadgear 860 may be connected in a back portion such as through using aconnected region 67 or a unified strap as illustrated in FIG. 7 . If thenares portion 820 is provided with the structure adapted to connect to amouth portion, such as the connector 30 illustrated in FIG. 1-5 , thenthe mouth portion 840 provided in the mouth kit 810 may includestructure to connect the nares portion 820 to the mouth portion 840,such as opening 46 illustrated in FIG. 5-1 . The valve 55 and knob 54may also be provided.

In embodiments including the structure allowing pneumatic connectionbetween the nares portion 820 and the mouth portion 840, such as theconnector 30 and opening 46, the patient may connect the connector 30 tothe opening 46, and utilize the elbow or other connector 802 on thenares portion 820 to deliver the air to the patient's nares and todeliver the air to the patient's mouth through the connector 30 andopening 46 to the mouth portion 840. In this embodiment, the plug 803 isconnected to the opening on the front of the mouth portion 840.Structure for plugging the connection between the nares portion 820 andthe mouth portion 840 could be used, such as a plug 35 or the valve 55,and the mouth portion 840 could then be used as a mouth seal.

Alternatively, in embodiments including the structure allowing pneumaticconnection between the nares portion 820 and the mouth portion 840, suchas the connector 30 and opening 46, the patient may connect theconnector 30 to the opening 46, and utilize the plug 803 to plug theopening in the nares portion 820. The elbow or other connector 802 maythen be connected to the opening in the front of the mouth portion 840to deliver the pressurized air to the mouth portion 840, and through theconnector 30 and opening 46 to the nares portion 820. Structure forplugging the connection between the nares portion 820 and the mouthportion 840 could be used, such as a plug 35 or the valve 55, and thenares portion 820 could then be used as a nares seal.

The nares and mouth kit 801 may include the components of the nares onlykit 805 and the mouth kit 810. The nares and mouth kit 801 may allow apatient selectively switch between using the nares portion 820 alone, tousing the mouth portion 840 alone, or to use the nares portion 820 andthe mouth portion 840 together. This allows the patient to periodicallychange how the devices feel on the patients face. For example, if thepatient's nares area becomes irritated (e.g., by air jetting and/orconcentrated sealing forces), the patient may switch to using the naresportion 820 and the mouth portion 840, or the mouth portion 840 alone.The patient may switch on a periodic basis, e.g., nightly, weekly,monthly, etc.

FIG. 37 illustrates a prior art nares only CPAP device 901 that providesCPAP therapy to a patients nares. The CPAP device 901 may include anares portion 910 forming a seal with the patient's nares, an elbowconnector 912 connecting the nares portion 910 to a tube 915 supplyingpressurized gas to the nares portion 910, where the tube extends alongthe patient's nose, between the patient's eyes and over the patientshead, where it is connected to a supply of the pressurized gas. Theelbow connector may include a vent 914 for venting gas exhaled by thepatient, with the vent having a removable insert. The nares portion 910may include a nares sealing portion such as nasal pillows, nasal prongs,a nasal membrane, or a nasal chamber. Headgear 918 may secure the naresportion 910 to the patient's head.

FIG. 38 illustrates a side view of how the prior art nasal only device901 may be converted to a nares and mouth mask system 940 according toan embodiment of the present technology. The nares portion 910 and theelbow 912 may be removed and the mask system 940 including may beconnected to the tube 915, such as by a connector 924. The prior artnasal only device may be a “Breeze® Sleepgear®” device, for example.

The mask system 940 may include a mouth portion 942 for forming a sealwith the patient's mouth and a nares portion 952 for forming a seal withthe patient's nares. The mouth portion 942 may include headgearconnectors 946 for connecting to headgear 954, and the nares portion 952may include headgear connectors 944 for connecting to headgear 950. Themask system 940 may be a modular mask system or an integrated masksystem, and is capable of delivering pressurized air to the patient'snares and/or mouth.

The mask system 940 may alternatively utilize the nares portion 910, andadd a mouth portion, where the mask system 940 is a mouth portion. Inthis embodiment, the vent 914 of the elbow 912 is used for connection tothe mouth portion 940, where the insert in the vent 914 is removed, andthe mouth portion 940 is adapted to connect to the vent pneumatically.In this embodiment, air may flow out of the vent 914 to the mouthportion 940, and any original headgear, such as headgear 918 may beretained.

FIG. 39 illustrates a schematic side view of another modification of thenares only device 901. In this embodiment, the nasal pillows 960 areremoved from the openings 920 in the nares only device 901, and a masksystem 962 is connected to the nares only device 901 in place of thenasal pillows 960. The mask system 962 has a pair of connectors 964adapted to connect to the openings.

The mask system 962 includes a mouth portion 968 and a nares portion969. The mouth portion 968 forms a seal with a patient's mouth at mouthseal 974 and receives the pressurized air through the connectors 964.The mouth portion 968 is connected to the nares portion 969 with aconnector 976. The nares portion 969 may include nares engagementportion 970 adapted to form a seal with the patient's nares and supportportion 972. The nares portion 969 may alternatively be another type ofnares portion, such as nasal pillows or prongs, or a nasal chamber.

The mask systems 940 and 962 may be used to convert a nares only devicefor delivering respiratory therapy to a patient into a device fordelivering nasal and/or mouth respiratory therapy to a patient.

FIG. 40 illustrates a prior art nares only CPAP device 980 that providesCPAP therapy to a patient's nares. The CPAP device 980 may include anares portion 982 that includes a cushion 988 forming a seal with thepatient's nares, a connector 990 for connecting to a source ofpressurized gas, headgear connectors 985 for connecting to headgear anda forehead portion 984. The forehead portion 984 includes a foreheadsupport pad 986 and dial 994 for adjusting a position of the foreheadsupport pad 986. The cushion 988 may be removed by pulling it in thedirection of the arrows.

FIG. 41 illustrates a side view of how the prior art nasal only device980 may be converted to a nares and mouth mask system 993 according toan embodiment of the present technology. The cushion 988 may be removedand the nares and mouth mask system 993 may be connected to the nasalonly device in place of the cushion 988.

The nares and mouth mask system 993 may be adapted to connect to theframe of the nasal only device 980 in place of the cushion by beingformed with an interface 987 in the same shape as the cushion 988. Thenares and mouth mask system 993 includes a cushion 998 adapted to sealwith a face of the patient, and may include a nose engagement portion994 and a lower lip engagement portion 995. A headgear connector 996 mayconnect to headgear 997. The nares and mouth mask system 993 may thus beutilized to convert the nares only device 980 into a nares and mouthmask system 993. The front portion 999 of the mask system 993 may beformed with a rigidizer to provide additional rigidity.

The nares and mouth mask system 993 may include an AAV (anti-asphyxiavalve), which may have and opening 1002 and a flap 1004. When pressureis applied to the mask system 993 such as delivered from an air deliverytube, the flap 1004 is in the closed position. When no pressure isapplied, the flap 1004 moves to the open position 1006, allowing a userto breath through the opening 1002. While not shown, the embodiment ofFIG. 39 may also include such an AAV.

The mask systems described herein may be used to provide a method ofproviding respiratory therapy to one of a patient's nares only, apatient's mouth only, or to both a patient's nares and mouth, andperiodically changing the respiratory therapy to another of thepatient's nares only, the patient's mouth only, or to both the patient'snares and mouth. For example, the respiratory therapy may be initiallyprovided to the patient's nares only, and then periodically changed frombeing applied to the patient's nares only to being applied to thepatient's nares and mouth.

The mask systems described may also be utilized to provide a method ofrespiratory therapy treatment, where a first mask with a first footprintis applied to a patient for a period of time, then the first mask isremoved, and a second mask with a second footprint different from thefirst footprint is applied to the patient for a second period of time.For example, the first footprint may be one of a nares only mask, anares and mouth mask, and a mouth only mask, while the second footprintis another one of the nares only mask, the nares and mouth mask, and themouth only mask.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, bariatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike in non-medical applications.

What is claimed is:
 1. A mask system for delivery of respiratory therapyto a patient, comprising: a mouth portion comprising: a mouth cushionadapted to form a seal with the patient's mouth, the mouth cushioncomprising a recessed portion with a first outlet opening in a superiorregion of the mouth cushion; and a fascia that is more rigid than themouth cushion and forms a mouth plenum chamber together with the mouthcushion, the fascia comprising a headgear connector and an inletopening, the mouth plenum chamber being configured to receivepressurized, breathable gas through the inlet opening; a nares portionthat is configured to nest within the recessed portion of the mouthcushion and comprises: a nares sealing portion adapted to form a sealwith the patient's nares; and a plenum base that forms at least part ofa nares plenum chamber and includes a nares portion opening, the naresplenum chamber being configured to receive at least a portion of thepressurized, breathable gas from the mouth plenum chamber through thenares portion opening; and a cushion clip configured to secure the naresportion to the mouth portion, the cushion clip comprising: a wall thatis more rigid than the mouth cushion and the nares portion and forms atleast part of a gas flow passage that pneumatically connects the naresplenum chamber to the mouth plenum chamber when the cushion clip issecured to the mouth portion and the nares portion; a first flangepositioned on an outer surface of the wall, the first flange beinginserted through the nares portion opening to engage an interior surfaceof the plenum base; and a second flange configured to secure the cushionclip to the mouth cushion, wherein the recessed portion of the mouthcushion and first outlet opening are oriented so that the pressurized,breathable gas flowing through the cushion clip flows in a posteriordirection.
 2. The mask system according to claim 1, further comprisingan inlet conduit that is connectable to the fascia to deliver thepressurized, breathable gas to the mouth plenum chamber.
 3. The masksystem according to claim 2, further comprising a swivel ring in theinlet opening in the fascia adapted to connect to the inlet conduit. 4.The mask system according to claim 1, wherein the nares portion and themouth portion are formed separately from one another and then connectedto one another.
 5. The mask system according to claim 1, wherein thenares portion and the mouth portion are selectively connectable anddisconnectable from one another.
 6. The mask system according to claim1, wherein the mouth cushion is made of silicone.
 7. The mask systemaccording to claim 1, further comprising headgear configured to beconnected to the headgear connector on the fascia and support the mouthportion, and wherein the headgear includes lower side straps configuredto be routed under the patient's ears.
 8. The mask system according toclaim 7, wherein the headgear includes a crown strap portion adapted tobe positioned in use over the crown of the patient's head.
 9. The masksystem according to claim 8, wherein the headgear further includes arear strap portion configured to be positioned above the patient's earsand adapted to angle downward along the sides of the patient's head inuse to capture the occiput of the patient's head.
 10. The mask systemaccording to claim 9 wherein the rear strap portion is configured to beconnected to the lower side strap below the occiput of the patient'shead.
 11. The mask system according to claim 1, wherein the naressealing portion comprises one of pillows, prongs, a membrane seal, or anasal chamber.
 12. The mask system according to claim 11, wherein a wallof the plenum base of the nares sealing portion is structured to extendor curve outwardly from a rim of the nares portion opening.
 13. The masksystem according to claim 12, further comprising a plurality of rigidelements disposed on a lower side of the nares sealing portion, and adial connected to the rigid elements, the dial being configured so thatturning the dial causes the rigid elements to move upwards or downwardsto adjust a pinching force of the nares sealing portion.
 14. The masksystem according to claim 1, wherein the mouth portion further comprisesa second outlet opening below the first outlet opening, and wherein themouth cushion is configured so that the pressurized, breathable gas isdelivered to the patient's mouth through the second outlet opening. 15.The mask system according to claim 1, wherein the first outlet openingin the mouth cushion is below an uppermost portion of the mouth cushion.16. The mask system according to claim 15, wherein the recessed portionof the mouth cushion is configured so that a portion of the naresportion remains above the uppermost portion of the mouth cushion. 17.The mask system according to claim 1, wherein the recessed portion ofthe mouth cushion and the cushion clip are configured to allow the naresportion to move independently of the mouth portion when the naresportion is connected to the mouth portion.
 18. The mask system accordingto claim 1, wherein the wall forming the gas flow passage of the cushionclip is tubular.
 19. The mask system according to claim 1, wherein thenares portion is configured to receive the pressurized, breathable gasonly through the nares portion opening.
 20. The mask system according toclaim 1, wherein the nares portion and the mouth portion are formedseparately from one another and then connected to one another, whereinthe nares portion and the mouth portion are selectively connectable anddisconnectable from one another, wherein the mouth cushion is made ofsilicone, wherein the nares sealing portion comprises one of pillows,prongs, a membrane seal, or a nasal chamber, wherein a wall of theplenum base of the nares sealing portion is structured to extend orcurve outwardly from a rim of the nares portion opening, wherein themouth portion further comprises a second outlet opening below the firstoutlet opening, wherein the mouth cushion is configured so that thepressurized, breathable gas is delivered to the patient's mouth throughthe second outlet opening, wherein the first outlet opening in the mouthcushion is below an uppermost portion of the mouth cushion, wherein therecessed portion of the mouth cushion is configured so that a portion ofthe nares portion remains above the uppermost portion of the mouthcushion, wherein the recessed portion of the mouth cushion and thecushion clip are configured to allow the nares portion to moveindependently of the mouth portion when the nares portion is connectedto the mouth portion, and wherein the wall forming the gas flow passageof the cushion clip is tubular.
 21. The mask system according to claim20, further comprising: an inlet conduit that is connectable to thefascia to deliver the pressurized, breathable gas to the mouth plenumchamber; and headgear configured to be connected to the headgearconnector on the fascia and support the mouth portion, wherein theheadgear includes lower side straps configured to be routed under thepatient's ears, wherein the headgear includes a crown strap portionadapted to be positioned over the crown of the patient's head, whereinthe headgear includes a rear strap portion configured to be routed abovethe patient's ears and adapted to angle downward along the sides of thepatient's head in use to capture the occiput of the patient's head, andwherein the rear strap portion is configured to be connected to thelower side strap below the occiput of the patient's head.